Clinical trial NCT03015415: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Elbow range of motion improvement in degrees
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia
Study officials:
affiliation: University of Sao Paulo
name: Rames M Junior, Professor
role: STUDY_CHAIR
References: