The Posttraumatic Elbow Stiffness Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03015415|
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Elbow Joint Contracture Elbow Flexion Contractures Elbow Injury Elbow Osteoarthritis||Procedure: Elbow Open Arthrolyses Procedure: Non-surgical intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Prospective Randomized Controlled Trial of Open Arthrolysis Versus Non-surgical Treatment for Elbow Stiffness|
|Actual Study Start Date :||March 3, 2013|
|Actual Primary Completion Date :||September 20, 2018|
|Actual Study Completion Date :||October 12, 2018|
Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses
Procedure: Elbow Open Arthrolyses
Elbow arthrolysis by posterior access
Other Name: surgical
Patients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention
Procedure: Non-surgical intervention
Rehabilitation with splinting protocols
- Elbow range of motion improvement in degrees [ Time Frame: 6 months ]The gain will be measured with a goniometer centered on the axis of rotation of the elbow by a external examiner.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015415
|Instituto de Ortopedia e Traumatologia|
|Sao Paulo, Brazil, 05403-010|
|Study Chair:||Rames M Junior, Professor||University of São Paulo|