The Posttraumatic Elbow Stiffness Treatment

NCT ID: NCT03015415

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-03
• Study Completion Date: 2018-10-12

Brief Summary

This study compares patients with post traumatic elbow stiffness and evaluate the range of motion improvement with two types of treatment: surgical release versus non-surgical rehabilitation protocol with orthoses.

Detailed Description

The study of the treatment of post-traumatic stiffness of the elbow presents numerous challenges. Due to the great variability of the types of lesions, causes and symptomatology, there are great difficulties in the homogenization of protocols and in the comparison of results between the different treatments. Patients with different levels of severity and time of stiffness, presence of arthrosis or not, and significant symptoms such as pain.

For patients with elbow stiffness without vicious consolidation, pseudoarthrosis, intra-articular synthesis material or heterotopic ossification, and who have already failed conventional therapy, basically have two treatment options. Which will be the subject of this study: surgical release or non-surgical rehabilitation protocols with orthoses.

In meta-analysis, evaluating the elbow range of motion gain with rehabilitation protocols associated with orthoses, the mean gain varies from 20º to 40º, depending on the type of orthosis used. On the other hand a systematic review evaluated movement gain with different surgical techniques. Observed a mean gain of 51º for open releases, but with higher complication rates. However, there are no comparative studies in the literature comparing this 2 types of treatment for post traumatic elbow stiffness: surgical release and non-surgical rehabilitation protocol with orthoses in patients who have already performed conventional physiotherapy with no success.

Conditions

Elbow Joint Contracture; Elbow Flexion Contractures; Elbow Injury; Elbow Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

surgical

Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses

Group Type: EXPERIMENTAL

Elbow Open Arthrolyses

Intervention Type: PROCEDURE

Elbow arthrolysis by posterior access

non-surgical

Patients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention

Group Type: EXPERIMENTAL

Non-surgical intervention

Intervention Type: PROCEDURE

Rehabilitation with splinting protocols

Interventions

Elbow Open Arthrolyses

Elbow arthrolysis by posterior access

Intervention Type: PROCEDURE

Non-surgical intervention

Rehabilitation with splinting protocols

Intervention Type: PROCEDURE

Other Intervention Names

surgical

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

César Luiz Betoni Guglielmetti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rames M Junior, Professor

Role: STUDY_CHAIR

University of Sao Paulo

Locations

Instituto de Ortopedia e Traumatologia

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

Clbguglielmetti

Identifier Type: -

Identifier Source: org_study_id