The Posttraumatic Elbow Stiffness Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Elbow Joint Contracture; Elbow Osteoarthritis; Elbow Injury; Elbow Flexion Contractures
• Intervention / Treatment: Procedure: Elbow Open Arthrolyses; Procedure: Non-surgical intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-010
    • Instituto de Ortopedia e Traumatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: surgical; Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses	Procedure: Elbow Open Arthrolyses; Elbow arthrolysis by posterior access; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Rames M Junior, Professor, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2013
• Primary Completion (ACTUAL): September 20, 2018
• Study Completion (ACTUAL): October 12, 2018

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (ESTIMATE): January 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 16, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; elbow; Splint; Effectiveness of bracing; posttraumatic stiffness; elbow contractures; stiff elbow; dynamic orthoses; Dynamic splint
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Contracture
• Other Study ID Numbers: Clbguglielmetti

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO