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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT03015415

First Posted

January 5, 2017

Last Updated

May 16, 2020

Sponsor

University of Sao Paulo

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

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

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The Posttraumatic Elbow Stiffness Treatment

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