Clinical Trials Directory

Trials / Completed

CompletedNCT03015415

The Posttraumatic Elbow Stiffness Treatment

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
University of Sao Paulo · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREElbow Open ArthrolysesElbow arthrolysis by posterior access
PROCEDURENon-surgical interventionRehabilitation with splinting protocols

Timeline

Start date
2013-03-03
Primary completion
2018-09-20
Completion
2018-10-12
First posted
2017-01-10
Last updated
2020-05-19

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03015415. Inclusion in this directory is not an endorsement.