CoxarthrosisNCT04570748
Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.
A study testing Capsule repair and capsulectomy in people with Coxarthrosis, run by Bezmialem Vakif University.
Trial summary
Total hip arthroplasty is a successful surgical procedure performed as a last-line treatment in primary and secondary coxarthrosis. Recently, the direct anterior approach (DAA) has gained popularity by maintaining abduction force and reducing dislocation rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- Capsule repair and capsulectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2020to 30 Jul 2022
- 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
- Elective unilateral or bilateral primary total hip arthroplasty
- Direct anterior surgical approach
- 18 years of age or older
- Avascular necrosis of the hip
Who cannot join
- Rheumatoid arthritis of the hip
- Revision hip arthroplasty
- Younger than 18 years of age
- Crowe type 3 and 4 coxarthrosis
About this study
Total hip arthroplasty is a successful surgical procedure performed as a last-line treatment in primary and secondary coxarthrosis.
Recently, the direct anterior approach (DAA) has gained popularity by maintaining abduction force and reducing dislocation rates.
Soft tissue stability in the anterior is increased by adding capsule repair with the preservation of the posterior structures in the DAA.
The degradation of the biological structure of the capsule due to degenerative changes in the end stage coxarthrosis questions the effectiveness of the capsule repair. therefore, the effect of capsule repair on stability is still controversial.
- Conditions
- Coxarthrosis
- Being tested
- Capsule repair, capsulectomy
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule repairProcedure or surgery
Direct anterior hip arthroplasty with or without capsule repair
capsulectomyProcedure or surgery
capsulectomy without repair
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Direct anterior hip arthroplasty with capsule repair. Receives: Procedure: Capsule repair |
| Group B | Active comparator | Surgery that the surgeon will not perform capsule repair after performing an initial capsulectomy during total hip arthroplasty Receives: Procedure: capsulectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvis magnetic resonance ımages(MRI) evaluation of patients who underwent direct anterior total hip arthroplasty
The new capsule mass will be evaluated by an independent radiologist. adiologist will evaluate the volume of the new capsule structure in cubic millimeter
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start30 Nov 2020 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Sarikas, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570748
- Sponsor's protocol ID
- 32495008292
- Status last verified
- Sep 2020
- First submitted
- 23 Jul 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.
- ClinicalTrials.gov ID
- NCT04570748
- Acronym / sponsor ID
- 32495008292
- Conditions
- Coxarthrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 30 Sep 2020 (actual)
- 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.
Total hip arthroplasty is a successful surgical procedure performed as a last-line treatment in primary and secondary coxarthrosis.
Recently, the direct anterior approach (DAA) has gained popularity by maintaining abduction force and reducing dislocation rates.
Soft tissue stability in the anterior is increased by adding capsule repair with the preservation of the posterior structures in the DAA.
The degradation of the biological structure of the capsule due to degenerative changes in the end stage coxarthrosis questions the effectiveness of the capsule repair. therefore, the effect of capsule repair on stability is still controversial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Capsule repairDirect anterior hip arthroplasty with capsule repair. |
| Group B | Active comparator | Procedure: capsulectomySurgery that the surgeon will not perform capsule repair after performing an initial capsulectomy during total hip arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective unilateral or bilateral primary total hip arthroplasty
- Direct anterior surgical approach
- 18 years of age or older
- Avascular necrosis of the hip
Key exclusion criteria (4 listed)
- Rheumatoid arthritis of the hip
- Revision hip arthroplasty
- Younger than 18 years of age
- Crowe type 3 and 4 coxarthrosis
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 |
|---|---|---|
| Capsule repairDirect anterior hip arthroplasty with or without capsule repair | Procedure or surgery | Group A |
| capsulectomycapsulectomy without repair | Procedure or surgery | Group B |
Primary outcome
Pelvis magnetic resonance ımages(MRI) evaluation of patients who underwent direct anterior total hip arthroplasty
Time frame: one year
The new capsule mass will be evaluated by an independent radiologist. adiologist will evaluate the volume of the new capsule structure in cubic millimeter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Capsule repair and capsulectomy in people with Coxarthrosis, run by Bezmialem Vakif University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Pelvis magnetic resonance ımages(MRI) evaluation of patients who underwent direct anterior total hip arthroplasty (time frame: one year). 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 30 Sep 2020.