CoxarthrosisNCT04500093
Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?
A study testing Capsulotomy with Repair and Capsuloectomy in people with Coxarthrosis and Muscle Weakness, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Total hip arthroplasty (THA) has been successful in relieving pain and restoring function in patients with advanced arthritis of the hip joint. Increased focus on earlier recovery and decreased postoperative pain has improved overall satisfaction. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Coxarthrosis, Muscle Weakness
- What is being tested?
- Capsulotomy with Repair and Capsuloectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2020to 30 Nov 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All primary THA
Who cannot join
- Secondary THA
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34000
About this study
Total hip arthroplasty (THA) has been successful in relieving pain and restoring function in patients with advanced arthritis of the hip joint. Increased focus on earlier recovery and decreased postoperative pain has improved overall satisfaction. However, there is still a gap between the clinical scores in objective surveys and patient satisfaction. Direct anterior approach total hip arthroplasty has a low dislocation rate, abductor strength restoration, acceleration, and cosmetic advantages. In this method, capsulotomy with repair or capsulectomy is applied as the preferences of surgeons. Therefore, this can cause both a decrease in hip flexion strength and a loss in knee extension strength. Our aim in this study is to reveal how much muscle loss was caused by comparing both methods with the intact side.
Read the detailed description
Published data assessing biomechanical performance after THR are sparse. The majority of studies assessing post-THR hip function using robotic dynamometry have focused on evaluating surgical outcomes and prosthetic selection. These studies provide insight regarding the strength deficits of older adults after THR. However, the data are not consistent, making it difficult to assess the nature of the deficit.
- Conditions
- Coxarthrosis, Muscle Weakness
- Being tested
- Capsulotomy with Repair, Capsuloectomy
- Keywords
- Hip, Arthroplasty, Quadriceps strenght, Muscle Weakness, Knee, Flexion, Extension
- Medical subject headings
- Osteoarthritis, Hip, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsulotomy with RepairProcedure or surgery
Capsulotomy with Repair
CapsuloectomyProcedure or surgery
Capsuloectomy
| Study group | Role | What they receive |
|---|---|---|
| Capsulotomy with Repair | Experimental | Repair after capsulotomy in direct anterior hip arthroplasty Receives: Procedure: Capsulotomy with Repair |
| Capsuloectomy | Active comparator | Capsuloectomy in direct anterior hip arthroplasty Receives: Procedure: Capsuloectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Weakness
Newton
Measured: 1 year
Secondary outcomes (1)
Harris Hip Score
Score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start2 Aug 2020 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Nov 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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkhan Aliyev, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500093
- Sponsor's protocol ID
- 24959901
- Status last verified
- Aug 2020
- First submitted
- 1 Aug 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?
- ClinicalTrials.gov ID
- NCT04500093
- Acronym / sponsor ID
- 24959901
- Conditions
- Coxarthrosis, Muscle Weakness
- Keywords
- Hip, Arthroplasty, Quadriceps strenght, Muscle Weakness, Knee, Flexion, Extension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 2 Aug 2020 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 5 Aug 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 (THA) has been successful in relieving pain and restoring function in patients with advanced arthritis of the hip joint. Increased focus on earlier recovery and decreased postoperative pain has improved overall satisfaction. However, there is still a gap between the clinical scores in objective surveys and patient satisfaction. Direct anterior approach total hip arthroplasty has a low dislocation rate, abductor strength restoration, acceleration, and cosmetic advantages. In this method, capsulotomy with repair or capsulectomy is applied as the preferences of surgeons. Therefore, this can cause both a decrease in hip flexion strength and a loss in knee extension strength. Our aim in this study is to reveal how much muscle loss was caused by comparing both methods with the intact side.
Detailed description
Published data assessing biomechanical performance after THR are sparse. The majority of studies assessing post-THR hip function using robotic dynamometry have focused on evaluating surgical outcomes and prosthetic selection. These studies provide insight regarding the strength deficits of older adults after THR. However, the data are not consistent, making it difficult to assess the nature of the deficit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsulotomy with Repair | Experimental | Procedure: Capsulotomy with RepairRepair after capsulotomy in direct anterior hip arthroplasty |
| Capsuloectomy | Active comparator | Procedure: CapsuloectomyCapsuloectomy in direct anterior hip arthroplasty |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All primary THA
Key exclusion criteria (1 listed)
- Secondary THA
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 |
|---|---|---|
| Capsulotomy with RepairCapsulotomy with Repair | Procedure or surgery | Capsulotomy with Repair |
| CapsuloectomyCapsuloectomy | Procedure or surgery | Capsuloectomy |
Primary outcome
Muscle Weakness
Time frame: 1 year
Newton
1 secondary outcome
Harris Hip Score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: Yes
Related trials for Coxarthrosis
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Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
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Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
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DEXA Bone Density Analysis of the CoreHip® Prosthesis System
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsulotomy with Repair and Capsuloectomy in people with Coxarthrosis and Muscle Weakness, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 5 Aug 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orkhan Aliyev, MD (+90 505 991 71 19, orkhanaliyev@outlook.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Weakness (time frame: 1 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 5 Aug 2020.