The Posttraumatic Elbow Stiffness Treatment

Elbow Injury Clinical Trial

Official title:

A Prospective Randomized Controlled Trial of Open Arthrolysis Versus Non-surgical Treatment for Elbow Stiffness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015415
• Other study ID #: Clbguglielmetti
• Status: Completed
• Phase: N/A
• Start date: March 3, 2013
• Est. completion date: October 12, 2018

Study information

• Verified date: May 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 12, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Contracture
• Elbow Flexion Contractures
• Elbow Injury
• Elbow Joint Contracture
• Elbow Osteoarthritis

Intervention

Procedure:
• Elbow Open Arthrolyses
Elbow arthrolysis by posterior access
• Non-surgical intervention
Rehabilitation with splinting protocols

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia e Traumatologia	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months