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Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

BMC Musculoskeletal Disorders201415:252

DOI: 10.1186/1471-2474-15-252

Received: 26 September 2013

Accepted: 1 July 2014

Published: 25 July 2014

Abstract

Background

Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy.

Methods

We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann–Whitney test.

Results

The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck’s disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0–1) and for the shoulder RCTs 3.0 (range 0–5) (p = 0.012).

Conclusion

Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically performed wrist interventions has been studied in only 4 randomized studies compared to 50 randomized studies of significantly higher quality assessing interventions performed through shoulder arthroscopy.

Keywords

Arthroscopy Wrist Shoulder Randomized trials Jadad scale Intervention RCT Systematic review

Background

Although arthroscopy of upper extremity joints was initially introduced mainly for diagnostic purposes it is being increasingly used for therapeutic interventions [1]. For example, wrist interventions performed through arthroscopy include, among others, excision of wrist ganglia, treatment of acute fractures and of non-unions, ligament repair and reconstructions, repair or debridement of the triangular fibrocartilage complex, ulnar head resection, partial or total removal of carpal bones, and joint fusions [1, 2]. A recent study on musculoskeletal upper extremity ambulatory surgery in the United States estimated that 272,148 rotator cuff repairs, 257,541 shoulder arthroscopies excluding those for cuff repairs, 3686 elbow arthroscopies, and 25,250 wrist arthroscopies were performed in 2006 [3]. Arthroscopic interventions generally require special equipment and substantial surgical training and may thus be associated with higher costs than open procedures [4]. In addition, arthroscopic procedures may be associated with various complications [5]. Arthroscopic interventions may, however, be more cost-effective if their efficacy is superior to that of non-arthroscopic treatments or if they have similar efficacy but provide additional benefit, such as quicker recovery or lower morbidity. There is strong agreement that good-quality randomized controlled trials (RCTs) are the gold standard for assessing treatment efficacy and that they provide higher level of evidence than observational studies [6]. We reviewed the literature for intervention RCTs involving wrist arthroscopy, and for comparison, shoulder arthroscopy, hypothesizing that the quality of wrist and shoulder RCTs are similar.

Methods

We performed a systematic review of the literature for randomized or quasi-randomized clinical trials in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. An experienced researcher searched for articles published up to December 2012 in the databases PubMed and Cochrane Library. The search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [7]. The search strategy was applied to PubMed and optimized for the Cochrane database (Additional file 1). We included all RCTs written in English, Spanish, or German. We omitted conference abstracts. We checked the references of the initially included articles to identify other potentially relevant studies and subjected them to a similar selection process.

Three researchers reviewed the selected articles (each article reviewed by at least two researchers) and recorded the following data: the country where the study was conducted, the condition for which the interventions were done, the randomization method, the number of randomized participants, the time of randomization, the outcomes measures used, blinding, and description of dropouts and withdrawals. When appropriate we grouped the conditions for which the interventions were done into diagnostic categories. As a measure of RCT quality we used the Jadad scale [8] as modified by Gummesson et al. [9]. The scale considers the randomization method, blinding and description of dropouts/withdrawals, yielding a score from 0 (lowest quality) to 5 (highest) [9]. A study that describes an appropriate randomization method (such as computer-generated sequence or a random-number table) is awarded 2 points while a study that does not report the randomization method or reports an inappropriate method (such as order of presentation or medical record number) is not awarded any points. Similarly a study that reports blinding (single or double) using an appropriate method is awarded 2 points while use of an inappropriate blinding method or absence of blinding does not yield any points. The blinding method was considered appropriate if the article specified whom the blinding involved and, depending on the nature of the interventions, possible additional measures to ensure the blinding (for example, stating that blinding involved an assessor and that the surgical area was covered during patient assessment or that identical incisions were used for the different surgical procedures). Description of any dropouts or withdrawals (or a statement that no dropouts/withdrawals occurred) is awarded 1 point. The grading according to the modified Jadad scale was done by two researchers independently and any disagreements were resolved by discussion until consensus was reached.

The median modified Jadad scores were calculated for the wrist and shoulder RCTs and were then compared with the Mann–Whitney test. A p-value of less than 0.05 was considered to indicate statistical significance.

Results and discussion

Results

The Medline search showed that the first publications in which wrist arthroscopy or shoulder arthroscopy were mentioned appeared in the late 1970s.

Wrist arthroscopy

Of 7 possible RCTs obtained in the search, 3 were excluded because they involved postoperative analgesia, leaving 4 intervention RCTs eligible for inclusion (Figure 1; Additional file 2). The 4 RCTs (Table 1) involved Kienböck’s disease (arthroscopic versus open surgery), dorsal wrist ganglia (arthroscopic versus open excision), volar wrist ganglia (arthroscopic versus open excision), and distal radius fracture (arthroscopically- and fluoroscopically-assisted versus fluoroscopically-assisted reduction, followed by fixation). The number of participants in the 4 studies was 16, 50, 72, and 40, respectively (median 45).
https://static-content.springer.com/image/art%3A10.1186%2F1471-2474-15-252/MediaObjects/12891_2013_Article_2208_Fig1_HTML.jpg
Figure 1

RCTs involving wrist arthroscopy or shoulder arthroscopy – inclusion and exclusion flow diagram. Details of the inclusion and exclusion process of the finally selected intervention randomized controlled trials in which at least one arm involved wrist arthroscopy or shoulder arthroscopy; shown in a PRISMA flow diagram. W = number of wrist arthroscopy articles; S = number of shoulder arthroscopy articles.

Table 1

Details of the intervention randomized controlled trials in which at least one arm involved wrist arthroscopy or shoulder arthroscopy

Author* (first) yr

Country

Diagnosis

Intervention 1

N 1

D/W

Intervention 2

N 2

W/D

Randomization method

Time of randomization

Outcomes

Blinding

Wrist

            

Kang 2008

USA

Dorsal ganglion

Arthroscopic excision

41

13

Open excision

31

8

Medical record Identifier (odd/even)

At presentation

Recurrence, residual pain, complications

NR

Leblebicioglu 2003

Turkey

Kienböck’s disease

Open scaphocapitate fusion and lunate revascularization

8

NR

Arthroscopic scapho-capitate fusion and capitate pole excision

8

NR

Last digit of Medical record (odd/even)

NR

Operative time, LOHS, time to fusion, ROM, grip, RTW

NR

Rocchi 2008

Italy

Volar ganglion

Open excision

25

2

Arthroscopic excision

25

1

Sealed envelopes

NR

ROM, grip, scar, pain, residual symptoms, recurrence

NR

Varitimidis 2008

Greece

Intra-articular distal radius fracture

Arthroscopic and fluroscopic assisted reduction + external fixation and percutaneous pinning

20

NR

Fluroscopic assisted reduction + external fixation and percutaneous pinning

20

NR

Sealed envelopes

NR

Mayo wrist score, DASH (primary), clinical wrist instability, grip, ROM, radiographs

NR

Shoulder

            

Archetti Netto 2012

Brazil

Traumatic anterior instability + isolated Bankart lesion

Arthroscopic repair

22

5

Open repair

28

3

Computer; Sealed envelopes

At surgery

DASH (primary), UCLA, Rowe, ROM

NR

Barber 2012

USA, Canada

Large rotator cuff tear

Arthroscopic single- row repair + acellular human dermal matrix augmentation

22

NR

Arthroscopic single row repair

20

NR

Sealed envelopes

At surgery

ASES, UCLA, Constant, MRI, ROM, strength

Assessor (radiologist)

Berth 2010

Germany

Massive rotator cuff tear

Arthroscopic partial rotator cuff repair

21

NR

Arthroscopic debride-ment + subacromial decompression

21

NR

Patient's option

NR

Constant, ROM, pain, DASH, ultrasound

NR

Bottoni 2002

USA

Acute, traumatic, first-time shoulder dislocations in young athletes

Arthroscopic stabilization

10

1

Nonoperative treatment (4 wks immobilization followed by supervised rehabilitation program)

14

2

Last digit social security number (odd/even)

NR

Recurrent instability, SANE, L'Insalata shoulder evaluation, satisfaction

NR

Bottoni 2006

USA

Recurrent anterior shoulder instability

Arthroscopic stabilization

32

0

Open stabilization

32

3

Sealed envelopes

NR

ROM, stability, SANE, SST, WOSI, UCLA, Rowe

Assessor (physiotherapist)

Brox 1993

Norway

Impingement syndrome (stage II)

Arthroscopic acromioplasty

45

13

Supervised exercises; Placebo laser

50;30

8;4

NR

Mean 2 months before treatment

Neer shoulder score (primary), pain

Assessor

Burks 2009

Australia

Full-thickness rotator cuff tear

Arthroscopic single-row rotator cuff repair

20

0

Arthroscopic double-row rotator cuff repair

20

0

Random number Generator; Sealed envelopes

At surgery

UCLA, MRI, Constant-Murley, WORC, SANE, ASES, ROM, strength

Assessors (radiologist and examiner)

Charron 2007

USA

Distal clavicle osteolysis or post-traumatic acromio- clavicular arthrosis without instability

Arthroscopic distal clavicle resection with a direct approach

19

1

Arthroscopic distal clavicle resection with an indirect subacromial approach

19

3

Order of enrollment (odd/even)

At enrollment

ASES, ATH, time to full return to sports

NR

Chen 2010

China

Frozen shoulder

Arthroscopic release of anterior capsular structures

42

1

Arthroscopic release extended inferiorly and posteriorly

32

3

Computer; Sealed envelopes

At surgery

Constant, ROM

Patients and Assessors

De Carli 2012

Italy

Idiopathic adhesive shoulder capsulitis

Arthroscopy arthrolysis and shoulder manipulation

25

2

Glenohumeral steroid injections

21

0

NR

NR

ROM, ASES, UCLA, SST, Constant-Murley

NR

Dezaly 2011

France

Rotator cuff tear in the over-60s

Arthroscopic biceps acromioplasty-tenotomy and repair

71

3?

Arthroscopic biceps acromioplasty-tenotomy

71

12?

NR

Day before surgery

Constant, ultrasound tendon healing

NR

Elmlund 2009

Sweden

Recurrent shoulder instability

Arthroscopic reconstruction with polygluconate-B polymer

20

4

Arthroscopic reconstruction with poly-L-lactic acid polymer tack implants

20

3

Sealed envelopes

Just before surgery

Radiographs, CRP, Constant, Rowe, apprehension test, strength, ROM, recurrence of instability

Assessor (radiologist)

Fabbriciani 2004

Italy

Traumatic anterior shoulder instability

Arthroscopic repair

30

NR

Open repair

30

NR

Computer

At surgery

Constant, Rowe

NR

Franceschi 2008

Italy

Rotator cuff tear and a type II SLAP lesion in the over-50s

Arthroscopic repair of both lesions

31

2

Arthroscopic rotator cuff tear repair without repair of the SLAP II lesion but with tenotomy of the long head of the biceps

32

5

Random number table; Sealed envelopes

At surgery

UCLA, ROM

NR

Freedman 2007

USA

Refractory acromioclavicular joint pain

Open distal clavicle excision

9

1

Arthroscopic distal clavicle excision

8

1

NR

NR

Pain VAS (primary). modified ASES, SF-36

NR

Gartsman 2004

USA

Full-thickness rotator cuff tear + type 2 acromion

Arthroscopic rotator cuff repair + subacromial decompression

47

NR

Arthroscopic rotator cuff repair without subacromial decompression

46

NR

Random number table

At surgery

ASES

Patients

Grasso 2009

Italy

Full-thickness rotator cuff tear

Arthroscopic single-row rotator cuff repair

40

3

Arthroscopic double-row rotator cuff repair

40

5

Computer

At surgery

DASH, Constant, strength

NR

Gumina 2012

Italy

Large full-thickness posterosuperior rotator cuff tear

Arthroscopic repair with platelet-leukocyte membrane

40

1

Arthroscopic repair

40

3

Randomization list; Sealed envelopes

3 days before surgery

Constant, MRI (primary), SST

Assessors

Haahr 2005

Denmark

Subacromial impingement

Arthroscopic subacromial decompression

45

4

Physiotherapy

45

2

Computer; Sealed envelopes

NR

Constant, pain VAS, ROM, strength, ADL

NR

Henkus 2009

Nether-lands

Primary subacromial impingement without rotator cuff rupture

Arthroscopic subacromial bursectomy

27

1

Debridement of subacromial bursa + arthroscopic acromioplasty

30

0

Automatically generated randomization code

NR

Constant, SST , pain VAS, functional impairment VAS

Assessor and group 1 patients

Hiemstra 2008

Canada

Shoulder instability

Open stabilization

24

0

Arthroscopic stabilization

24

0

Computer

NR

Strength (primary), ASES, ROM

Assessor

Husby 2003

Norway

Impingement syndrome (Neer grade II)

Arthroscopic subacromial decompression

20

5

Open subacromial decompression

19

0

Sealed envelopes

At surgery

UCLA, pain VAS, satisfaction VAS, strength, ROM

Assessor

Kasten 2011

Germany

Supraspinatus tendon rupture

Arthroscopic repair

17

3

Mini-open technique

17

1

Order of enrollment(first 17/ next 17)

NR

NSAID use, pain, Constant-Murley, ASES, MRI

Assessor (radiologist)

Ketola 2009

Finland

Shoulder impingement syndrome

Supervised exercise

70

4

Arthroscopic acromioplasty + supervised exercise

70

2

Computer;Sealed envelopes

NR

Pain VAS, ROM, strength (primary), cost-effectiveness

Assessor (physiotherapist)

Kim 2011

Korea

Rotator cuff tear + asymptomatic acromioclavicular arthritis

Arthroscopic distal clavicle resection with rotator cuff repair

31

2

Arthroscopic rotator cuff repair

52

4

Random number table

NR

ASES, UCLA, pain, AC joint tenderness, cross body adduction test

NR

Kirkley 1999

Canada

First traumatic anterior dislocation

Immediate arthroscopic stabilization

19

0

Immobilization and rehabilitation

21

2

NR

NR

WOSI, ROM, redislocation

Assessor

Koh 2011

South Korea

Rotator cuff tear

Arthroscopic single-row repair

37

6

Arthroscopic double-row repair

34

3

Computer

At surgery

Pain VAS, Constant, ASES, UCLA, re-tear, MRI

Assessors (radiologist and examiner)

Lindh 1993

Sweden

Shoulder impingement

Arthroscopic subacromial decompression

10

0

Open acromioplasty

10

0

NR

NR

Osteophyte recurrence, ROM, UCLA

NR

Ma 2012

Taiwan

Full-thickness rotator cuff tear

Arthroscopic single-row repair

32

5

Arthroscopic double-row repair

32

6

Computer; Sealed envelopes

At surgery

UCLA, ASES, strength, magnetic resonance arthrography

NR

MacDonald 2011

Canada

Full-thickness rotator cuff tear

Arthroscopic repair + acromioplasty

41

9

Arthroscopic repair

45

9

Computer; Sealed envelopes

At surgery

WORC (primary), ASES, revision

Patients and Assessor

Magnusson 2006

Sweden

Post-traumatic shoulder instability

Arthroscopic Bankart reconstruction with polygluconate co-polymer

20

0

Arthroscopic Bankart reconstruction with self-reinforced poly-L-lactic acid polymer

20

0

Sealed envelopes

Just before surgery

Strength, ROM, Rowe, Constant, stability, radiography

Assessor (radiologist)

Milano 2007

Italy

Full-thickness rotator cuff tear

Arthroscopic repair + subacromial decompression

40

3

Arthroscopic repair

40

6

Computer

At surgery

Constant, DASH

NR

Milano 2010

Italy

Recurrent traumatic anterior shoulder instability

Arthroscopic repair with metal suture anchor

39

3

Arthroscopic repair with biodegradable suture anchor

39

5

Random sequence generator; Sealed envelopes

At surgery

DASH (primary),,Rowe, Constant, recurrence

Assessor

Milano 2010

Italy

Full-thickness rotator cuff tear

Arthroscopic repair with metal suture anchor

55

3

Arthroscopic repair with biodegradable suture anchor

55

6

Random sequence generator

At surgery

DASH, Constant

Assessor

Mohtadi 2008

Canada

Full-thickness rotator cuff tear

Open repair

37

8

Arthroscopic acromioplasty with mini-open repair

36

5

Computer; Sealed envelopes

NR

RC-QOL (primary), ASES, SRQ, FSET, ROM, strength

Assessor

Monteiro 2008

Brazil

Traumatic anterior shoulder instability

Arthroscopic repair with anchors loaded with absorbable sutures

25

4

Arthroscopic repair with anchors loaded with nonabsorbable sutures

25

1

Sealed envelopes

NR

Rowe, ASOSS

Assessor

Oh 2011

South Korea

Partial- or full- thickness rotator cuff tear

Arthroscopic repair + HA/carboxymethylated cellulose injection

40

NR

Arthroscopic repair

40

NR

Computer

NR

Pain VAS, PROM, ASES, ultrasonography, CTA

Injection and Assessor

Randelli 2011

Italy

Complete rotator cuff tear

Arthroscopic repair + autologous platelet rich plasma

26

4

Arthroscopic repair

27

4

Computer; Sealed envelopes

At surgery

Pain VAS, SST, UCLA, Constant, strength, MRI

Assessors (radiologist and examiner)

Robinson 2008

UK

First-time traumatic anterior dislocation

Arthroscopic examination and lavage

45

3

Arthroscopic examination and Bankart lesion repair

43

1

Computer; weighted minimization

NR

Recurrence, functional scores, DASH, patient satisfaction, SF-36, WOSI, ROM, cost

Patients and Assessor (physiotherapist)

Rodeo 2012

USA

Full-thickness rotator cuff tear

Arthroscopic repair + platelet-rich fibrin matrix

40

5

Arthroscopic repair

39

7

Sealed envelopes

At surgery

Healing on ultrasound (primary), ASES, L'Insalata, manual muscle testing

Patients and Assessor

Sachs 1994

USA

Impingement syndrome (stage II)

Arthroscopic acromioplasty

22

3

Open acromioplasty

22

0

NR

NR

Pain, function, ROM, strength, RTA, LOHS

NR

Shin 2012

South Korea

Small-medium rotator cuff tear

Arthroscopic repair + acromioplasty

75

15

Arthroscopic repair

75

15

NR

Before surgery

VAS, UCLA, ASES, Constant, MRI, ROM

NR

Shin 2012

South Korea

Partial-thickness articular-sided rotator cuff tear

Arthroscopic repair with transtendon technique

24

0

Arthroscopic repair with full-thickness conversion

24

0

Computer

At surgery

Pain and satisfaction VAS, ASES, Constant, MRI, ROM

Assessors (radiologist and examiner)

Silberberg 2011

Spain

Isolated type II SLAP lesion

Arthroscopic repair with vertical suture

15

0

Arthroscopic repair with horizontal suture

17

0

Minimization

At surgery

Pain and instability VAS, ASES, ROM

Assessor

Spangehl 2002

Canada

Impingement syndrome

Arthroscopic acromioplasty

32

?/25

Open acromioplasty

30

?/25

NR

NR

Pain and function VAS (primary), UCLA, satisfaction, strength

Assessor

Sperber 2001

Sweden

Traumatic anterior shoulder instability

Arthroscopic stabilization

30

NR

Open stabilization

26

NR

Sealed envelopes

At surgery

Recurrence, ROM, apprehension sign, relocation test, Constant, Rowe

NR

Syed 2010

USA

Soft tissue fluid retention after shoulder arthroscopy

Fenestrated outflow cannula

14

0

Conventional cannula

14

0

Sealed envelopes

NR

Fluid weight gain

Patients

Tan 2006

UK

Recurrent traumatic anterior instability

Arthroscopic Bankart repair with nonabsorbable anchor

65

2

Arthroscopic Bankart repair with absorbable anchor

65

4

Sealed envelopes

At surgery

OISS, pain and instability VAS, SF-12, recurrence

Patients and Assessors

Taverna 2007

Italy

Chronic supraspinatus tendinosis

Arthroscopic subacromial decompression

30

0

Radiofrequency-based plasma microtenotomy

30

0

Sealed envelopes

Just before surgery

Pain VAS, Constant, ASES, UCLA, SF-36

Patients and Assessor (physician)

Wintzell 1996

Sweden

Acute traumatic primary anterior dislocation

Arthroscopic lavage

15

0

Conservative treatment

15

0

NR

NR

Recurrenc, apprehension test, ROM, Lysholm score

Assessor

*The references are listed in Additional file 2.

Dropouts/withdrawals were mentioned but the exact number in each group was not clear in the article.

Abbreviations in alphabetical order:

ADL Activities of Daily Living, ASES American Shoulder and Elbow Surgeons shoulder score, ASOSS Athletic Shoulder Outcome Scoring System, ATH Athletic Shoulder Scoring System score, Constant Constant shoulder score, CRP C-Reactive Protein, CTA Computed Tomography Arthrography, DASH Disabilities of the Arm, Shoulder and Hand score, D/W dropouts/withdrawals, FSET Functional Shoulder Elevation Test, LOHS length of hospital stay, MRI Magnetic Resonance Imaging, N number of patients randomized, NR not reported, OISS Oxford Instability Shoulder Score, PROM Passive Range Of Motion, RC-QOL Rotator Cuff Quality Of Life score, ROM Range Of Motion, Rowe Rowe shoulder score, RTA return to activities, RTW return to work, SANE Single Assessment Numeric Evaluation score, SF-12 Short Form 12 survey, SF-36 Short Form 36 survey, SRQ Shoulder Rating Questionnaire, SST Simple Shoulder Test, UCLA University of California-Los Angeles shoulder rating scale, VAS Visual Analogue Scale, WORC Western Ontario Rotator Cuff index, WOSI Western Ontario Shoulder Instability index.

Shoulder arthroscopy

Of 130 possible RCTs obtained in the search, 80 were excluded: 24 were not intervention RCTs (matched cohort or cross-sectional studies, non-clinical RCTs, RCT protocols), 10 were systematic reviews or meta-analyses, 32 involved anesthesia or postoperative analgesia, 7 involved physiotherapy/postoperative rehabilitation, 6 were subsequent publications of same RCT, and 1 was not intervention through arthroscopy (after review of full-text and contact with the author). Thus, 50 shoulder intervention RCTs were included (Figure 1; Additional file 2). The 50 RCTs (Table 1) involved rotator cuff tears (n = 22), instability (n = 14), impingement (n = 9), and other conditions (n = 5). The interventions compared were different arthroscopic procedures (n = 31), arthroscopic versus open procedures (n = 12), and arthroscopic procedure versus nonoperative treatment (n = 7). The median number of participants was 60 (range 17–150).

Trial quality

Of the 4 wrist studies 2 used inappropriate randomization methods and the remaining 2 stated use of “sealed envelopes” but without reporting how the randomization sequence was generated. None of the studies reported blinding and only 2 provided information about dropouts/withdrawals. In the 50 shoulder RCTs, the randomization method was described and appropriate in 25 (50%), described but inappropriate in 18 (36%) and was not described in 7 (14%). Blinding using an appropriate method was reported in 23 studies (46%), blinding was reported but the method was inappropriate in 5 (10%) and blinding was not reported in 22 studies (44%). Dropouts/withdrawals were described in 41 (82%).

The median modified Jadad score for the wrist arthroscopy intervention RCTs was 0.5 (range 0–1) and for the shoulder arthroscopy intervention RCTs was 3.0 (range 0–5). The quality of the shoulder RCTs was significantly higher than that for the wrist RCTs (p = 0.012).

Discussion

Our study shows that despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically performed interventions has only been studied in 4 quasi-randomized studies. This can be compared to 50 randomized or quasi-randomized studies of significantly higher quality for arthroscopically performed shoulder interventions, yet both procedures were first described in the literature in the late 1970s.

Since their introduction as diagnostic tools, both wrist and shoulder arthroscopy have undergone technical advancement and broader clinical applications. However, they appear to diverge in the extent to which they have been evaluated scientifically. It might be argued that shoulder disorders are more common and therefore it would be easier to conduct randomized trials. However, wrist arthroscopy is being used for several wrist disorders that are relatively common. Besides, multicenter trials can be conducted when a condition is not that common to allow enrollment of an adequate number of patients in a reasonable time. In contrast to wrist arthroscopy, endoscopic carpal tunnel release, an arthroscopic procedure, first described in the literature in the late 1980s, has been evaluated in numerous intervention RCTs, including a number of high quality trials as judged by the Cochrane reviews [10]. Also, our review of shoulder arthroscopy RCTs shows that it is possible to conduct good-quality surgical intervention trials involving arthroscopy.

Arthroscopic interventions are now used for new areas in upper extremity surgery such as thumb carpometacarpal osteoarthritis, a common condition, still without evidence from randomized studies. Because conducting good-quality surgical RCTs, with the many factors involved, is generally more difficult than pharmaceutical trials, proposals have been presented recently to facilitate surgical trials [11, 12]. The lack of high-level evidence, based on good-quality randomized trials, to support the large number of surgical interventions performed through wrist arthroscopy should be a concern not only to health care payers and providers but also to patients.

Like other quality assessment systems, the Jadad scale has its limitations. Although the scale considers the appropriateness of the randomization method, which is fundamental, it does not include concealment. We have however extracted the data concerning concealment for each trial, when such data were reported (Table 1). Further, blinding of patients may not be feasible in surgical interventions. However, we also considered blinding of outcome assessors and this should be feasible in surgical trials. Another limitation is the possible existence of RCTs that the search did not capture. However, we do not believe that the search missed any eligible wrist intervention RCTs.

It is highly unlikely that a study that had used blinding or achieved complete follow-up with no drop-outs or withdrawals would not report these in the published article as important strengths. We considered studies that only mentioned using “sealed envelopes” without specifying how the randomization sequence was generated (2 wrist studies and 11 shoulder studies) as not having reported the randomization method and thus were not awarded any points for randomization. Even if we assume that these studies had used appropriate methods in generating the randomization sequence the results would be similar (median score 1.5 vs 3.0; p = 0.041).

In our search we could not find any previous studies that have assessed the quality of intervention trials involving wrist arthroscopy. With regard to RCTs that involved shoulder arthroscopy, there have been systematic reviews of intervention trials for specific shoulder disorders that included interventions done through arthroscopy. Most of these reviews used different quality scales and therefore could not be compared directly with our study. For example, a systematic review of interventions for anterior shoulder instability assessed the quality of 3 trials with a 12-item scale that included concealment and blinding (each item scored 0, 1 or 2 for a best possible total score of 24 points) giving them a score of 17, 16 and 15, respectively [13]. The modified Jadad score for the same 3 trials in our study was 3, 2 and 0, respectively, which reflects the fact that the modified Jadad scale focuses on the unambiguous reporting of the fundamental issues of randomization, blinding and drop-outs/withdrawals.

In one previous systematic review that used the original Jadad scale in assessing the quality of 54 rotator cuff RCTs published from 2001 to 2011, the mean Jadad score was 3.0 [14]. The authors concluded that most trials were of high quality (66% had a Jadad score >3.0) but because almost two-thirds of the high-quality studies were nonoperative trials they suggested that the rotator cuff literature lacks high quality RCTs that are relevant to surgical clinical practice [14]. In another report based on the “comparative effectiveness of nonoperative and operative treatments for rotator cuff tears” systematic review of literature from 1990 to 2009, the authors concluded that the “RCT literature was of particularly low quality with high risk of bias from the manner in which the studies had been conducted” [15]. Thus, despite our finding that most intervention RCTs involving shoulder arthroscopy were of significantly higher quality than the very few wrist arthroscopy trials that have been performed, there is need for further improved shoulder surgical RCTs. For example, six RCTs (published since 2002) that have assessed the efficacy of knee arthroscopy in the treatment of osteoarthritis [16] are probably of substantially higher quality than most shoulder arthroscopy RCTs.

In a study that estimated the number of upper extremity ambulatory procedures performed in the United States in 2006, including wrist and shoulder arthroscopic interventions, the authors concluded that the resources utilized by these procedures are substantial and suggested that evidence-based clinical indications and outcomes of many of these upper extremity procedures remain poorly defined [3]. For interventions involving wrist arthroscopy, our systematic review shows that there is currently a lack of good evidence supporting the efficacy of these procedures.

Conclusions

This systematic review revealed that the efficacy of arthroscopically performed wrist interventions has been studied in only 4 quasi-randomized studies compared to 50 randomized or quasi-randomized studies of significantly higher quality assessing interventions performed through shoulder arthroscopy. In order to advance evidence-based care of patients with wrist disorders, there is a need for high-quality RCTs designed to assess the efficacy of the procedures currently performed through wrist arthroscopy.

Declarations

Acknowledgements

This research was supported and partially funded by Hässleholm Hospital. The funder had no role in the design, the collection, analysis and interpretation of data, the writing of the manuscript or the decision to submit the manuscript for publication.

Authors’ Affiliations

(1)
Department of Orthopedics, Hässleholm Hospital
(2)
Unit for Hand & Microsurgery, GECOT
(3)
Department of Clinical Sciences, Lund University

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  17. Pre-publication history

    1. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/15/252/prepub

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© Tadjerbashi et al.; licensee BioMed Central Ltd. 2014

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