Elbow Joint ContractureNCT03015415
The Posttraumatic Elbow Stiffness Treatment
A study testing Elbow Open Arthrolyses and Non-surgical intervention in people with Elbow Joint Contracture and Elbow Flexion Contractures, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Joint Contracture, Elbow Flexion Contractures, Elbow Injury
- What is being tested?
- Elbow Open Arthrolyses and Non-surgical intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Mar 2013to 12 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Elbow Open Arthrolyses, Non-surgical intervention
- Keywords
- elbow, posttraumatic stiffness, elbow contractures, stiff elbow, dynamic orthoses, Dynamic splint, Rehabilitation, Splint, Effectiveness of bracing
- Medical subject headings
- Elbow Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow Open ArthrolysesProcedure or surgery
Also called surgical
Elbow arthrolysis by posterior access
Non-surgical interventionProcedure or surgery
Rehabilitation with splinting protocols
| Study group | Role | What they receive |
|---|---|---|
| surgical | Experimental | Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses Receives: Procedure: Elbow Open Arthrolyses |
| non-surgical | Experimental | Patients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention Receives: Procedure: Non-surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start3 Mar 2013
- Primary completion20 Sep 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow Joint ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Luiz Betoni Guglielmetti, University of Sao Paulo
- Investigators
- Rames M Junior, Professor, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015415
- Sponsor's protocol ID
- Clbguglielmetti
- Status last verified
- May 2020
- First submitted
- 5 Jan 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Open Arthrolysis Versus Non-surgical Treatment for Elbow Stiffness
- ClinicalTrials.gov ID
- NCT03015415
- Acronym / sponsor ID
- Clbguglielmetti
- Keywords
- elbow, posttraumatic stiffness, elbow contractures, stiff elbow, dynamic orthoses, Dynamic splint, Rehabilitation, Splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 3 Mar 2013 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical | Experimental | Procedure: Elbow Open ArthrolysesPatients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses |
| non-surgical | Experimental | Procedure: Non-surgical interventionPatients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elbow Open ArthrolysesAlso: surgicalElbow arthrolysis by posterior access | Procedure or surgery | surgical |
| Non-surgical interventionRehabilitation with splinting protocols | Procedure or surgery | non-surgical |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rames M Junior, Professor study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elbow Open Arthrolyses and Non-surgical intervention in people with Elbow Joint Contracture and Elbow Flexion Contractures, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elbow range of motion improvement in degrees (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.