The Posttraumatic Elbow Stiffness Treatment
Primary Purpose
Elbow Joint Contracture, Elbow Flexion Contractures, Elbow Injury
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Elbow Open Arthrolyses
Non-surgical intervention
Sponsored by
About this trial
This is an interventional treatment trial for Elbow Joint Contracture focused on measuring elbow, posttraumatic stiffness, elbow contractures, stiff elbow, dynamic orthoses, Dynamic splint, Rehabilitation, Splint, Effectiveness of bracing
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).
Sites / Locations
- Instituto de Ortopedia e Traumatologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
surgical
non-surgical
Arm Description
Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses
Patients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention
Outcomes
Primary Outcome Measures
Elbow range of motion improvement in degrees
The gain will be measured with a goniometer centered on the axis of rotation of the elbow by a external examiner.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03015415
Brief Title
The Posttraumatic Elbow Stiffness Treatment
Official Title
A Prospective Randomized Controlled Trial of Open Arthrolysis Versus Non-surgical Treatment for Elbow Stiffness
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2013 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
October 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Joint Contracture, Elbow Flexion Contractures, Elbow Injury, Elbow Osteoarthritis
Keywords
elbow, posttraumatic stiffness, elbow contractures, stiff elbow, dynamic orthoses, Dynamic splint, Rehabilitation, Splint, Effectiveness of bracing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgical
Arm Type
Experimental
Arm Description
Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses
Arm Title
non-surgical
Arm Type
Experimental
Arm Description
Patients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention
Intervention Type
Procedure
Intervention Name(s)
Elbow Open Arthrolyses
Other Intervention Name(s)
surgical
Intervention Description
Elbow arthrolysis by posterior access
Intervention Type
Procedure
Intervention Name(s)
Non-surgical intervention
Intervention Description
Rehabilitation with splinting protocols
Primary Outcome Measure Information:
Title
Elbow range of motion improvement in degrees
Description
The gain will be measured with a goniometer centered on the axis of rotation of the elbow by a external examiner.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rames M Junior, Professor
Organizational Affiliation
University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Ortopedia e Traumatologia
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Posttraumatic Elbow Stiffness Treatment
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