The Posttraumatic Elbow Stiffness Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03015415
• Date of registration: 05/01/2017
• Prospective Registration: No
• Primary sponsor: University of Sao Paulo
• Public title: The Posttraumatic Elbow Stiffness Treatment
• Scientific title: A Prospective Randomized Controlled Trial of Open Arthrolysis Versus Non-surgical Treatment for Elbow Stiffness
• Date of first enrolment: March 3, 2013
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03015415
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Rames M Junior, Professor
• Affiliation: University of São Paulo

Key inclusion & exclusion criteria

Inclusion Criteria:

- Previous history of trauma that evolved with joint stiffness at the elbow

- Range of movement of the elbow less than 100º or extension deficit greater than 30º or
flexion less than 130º

- More than six months from the initial trauma;

- Skeletal maturity;

- Have had previous physical therapy without the use of orthotics or continuous passive
motion for at least 4 months;

- Absence of the following findings:

- Joint block, with range of motion equal to 0º;

- Neurological limb injury;

- Mental illness or inability to understand preoperative questionnaires;

- Active infection;

- Anterior infection at the elbow;

- Systemic autoimmune diseases. (Eg, systemic lupus erythematosus, rheumatoid arthritis,
joint psoriasis, etc.).

- Absence of the following radiographic changes:

- Intra-articular synthesis material;

- Presence of vicious consolidation of the distal articular surface of the humerus and
proximal ulna;

- Heterotopic ossification;

- Pseudoarthrosis of previous elbow fracture;

- Elbow incongruity;

- Grade III and IV arthrosis

Exclusion Criteria:

- Non-collaboration with rehabilitation program and postoperative follow-up;

- Need to use external fixator after surgical release due to joint instability;

- Death from non-intervention causes or loss of follow-up before the first functional
evaluation (3 months).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Elbow Injury

Elbow Joint Contracture

Elbow Osteoarthritis

Elbow Flexion Contractures

Intervention(s)

Procedure: Elbow Open Arthrolyses

Procedure: Non-surgical intervention

Primary Outcome(s)

Elbow range of motion improvement in degrees [Time Frame: 6 months]

Secondary ID(s)

Clbguglielmetti

Source(s) of Monetary Support

Please refer to primary and secondary sponsors