Skip to content

The Posttraumatic Elbow Stiffness Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03015415
Enrollment
30
Registered
2017-01-10
Start date
2013-03-03
Completion date
2018-10-12
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREElbow Open Arthrolyses

Elbow arthrolysis by posterior access

Rehabilitation with splinting protocols

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Elbow range of motion improvement in degrees6 monthsThe gain will be measured with a goniometer centered on the axis of rotation of the elbow by a external examiner.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026