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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
Sponsor:
Information provided by (Responsible Party):
César Luiz Betoni Guglielmetti, University of Sao Paulo

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: surgical
Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses
Procedure: Elbow Open Arthrolyses
Elbow arthrolysis by posterior access
Other Name: surgical

Experimental: non-surgical
Patients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention
Procedure: Non-surgical intervention
Rehabilitation with splinting protocols




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Locations
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Brazil
Instituto de Ortopedia e Traumatologia
Sao Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Study Chair: Rames M Junior, Professor University of São Paulo
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Responsible Party: César Luiz Betoni Guglielmetti, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03015415    
Other Study ID Numbers: Clbguglielmetti
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by César Luiz Betoni Guglielmetti, University of Sao Paulo:
elbow
posttraumatic stiffness
elbow contractures
stiff elbow
dynamic orthoses
Dynamic splint
Rehabilitation
Splint
Effectiveness of bracing
Additional relevant MeSH terms:
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Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases