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Table 1 Eligibility Criteria

From: PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2) – protocol for a multicenter randomized clinical trial

Inclusion Criteria

Exclusion Criteria

• Adults (≥ 18 years or older); skeletally mature

• Injury to the elbow with any of the following:

o Distal 1/3 humerus fracture (AO/OTA Type 13)

o Proximal 1/3 ulna fracture

(AO/OTA Type 2 U1)

o Proximal 1/3 radius fracture

(AO/OTA Type 2R1)

o Elbow dislocation

• Open fractures with/without nerve injury can be included

• Participant presents within 7 days or less between injury and trial recruitment

• Participant requires operative treatment of the fracture

• Participant has a negative urine pregnancy test

• Elbow specific

o Pre-existing elbow contracture, osteoarthritis, inflammatory arthritis, gout or non-specific monoarticular arthritis of the injured elbow

o Inability to mobilize elbow injury within 21 days of injury or surgery

o Total Elbow for fracture treatment

o Prior Elbow injury or surgery

o Bilateral elbow fractures and / or dislocations

• Medication contraindications

o Oral hypoglycemic medications

o History of epilepsy

o Lactose intolerance

o Any female who is pregnant or nursing

o Severe hepatic impairment

o Severe renal impairment

o Male or female of reproductive age unwilling to use 2 methods of contraception

• Participant specific

o Unable to maintain follow-up (no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.…)

o Has cognitive impairment or language difficulties that would impede the reliable completion of questionnaires

o Concomitant musculoskeletal or visceral injuries preventing elbow physiotherapy

o Unwilling or Unable to provide written informed consent.