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Completed

NCT Number: NCT03015415

The Posttraumatic Elbow Stiffness Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Ortopedia e Traumatologia

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Elbow Open Arthrolyses

Procedure

Elbow arthrolysis by posterior access

Other names: surgical

Non-surgical intervention

Procedure

Rehabilitation with splinting protocols

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2017
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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