Total Hip ArthroplastyNCT01621932
Anterior Capsulectomy vs. Repair in Direct Anterior THA
A study testing Direct anterior approach with capsulectomy and Direct anterior approach without capsulectomy in people with Total Hip Arthroplasty, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
Randomized prospective study comparing the anterior capsule repair vs capsulectomy with regards to post-operative pain and range of motion outcomes in elective primary unilateral direct anterior approach THA for osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Direct anterior approach with capsulectomy and Direct anterior approach without capsulectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2012to 2 Aug 2017
- 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 primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older
Who cannot join
- Bilateral primary total hip arthroplasty Revision hip arthroplasty Avascular necrosis of the hip Rheumatoid arthritis of the hip Younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoCarolina, P.A.
Charlotte, North Carolina, 28207
About this study
Randomized prospective study comparing the anterior capsule repair vs capsulectomy with regards to post-operative pain and range of motion outcomes in elective primary unilateral direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by goniometer measurements and lateral hip radiographs in maximum flexion.
The purpose of the study is to compare post-operative pain control and hip range of motion between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during direct anterior total hip arthroplasty.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Direct anterior approach with capsulectomy, Direct anterior approach without capsulectomy
- Keywords
- Anterior approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct anterior approach with capsulectomyProcedure or surgery
Direct anterior approach with capsulectomy
Direct anterior approach without capsulectomyProcedure or surgery
Direct anterior approach without capsulectomy
| Study group | Role | What they receive |
|---|---|---|
| Surgical approach 1 | Active comparator | Direct anterior surgical approach with capsulectomy Receives: Procedure: Direct anterior approach with capsulectomy |
| Surgical approach 2 | Active comparator | Direct anterior approach without capsulectomy Receives: Procedure: Direct anterior approach without capsulectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip flexion
Measured: postoperative 4 months
Secondary outcomes (1)
Visual analog scale-pain
Measured: 4 months and 12 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study start1 Mar 2012
- Primary completionDec 2016
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies 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
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Masonis, MD, Principal investigator, OrthoCarolina, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621932
- Sponsor's protocol ID
- 101105A
- Status last verified
- Jan 2021
- First submitted
- 14 Jun 2012
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Capsulectomy vs. Repair in Direct Anterior THA
- ClinicalTrials.gov ID
- NCT01621932
- Acronym / sponsor ID
- 101105A
- Conditions
- Total Hip Arthroplasty
- Keywords
- Anterior approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 18 Jun 2012 (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.
Randomized prospective study comparing the anterior capsule repair vs capsulectomy with regards to post-operative pain and range of motion outcomes in elective primary unilateral direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by goniometer measurements and lateral hip radiographs in maximum flexion.
The purpose of the study is to compare post-operative pain control and hip range of motion between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during direct anterior total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical approach 1 | Active comparator | Procedure: Direct anterior approach with capsulectomyDirect anterior surgical approach with capsulectomy |
| Surgical approach 2 | Active comparator | Procedure: Direct anterior approach without capsulectomyDirect anterior approach without capsulectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective unilateral primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older
Key exclusion criteria (1 listed)
- Bilateral primary total hip arthroplasty Revision hip arthroplasty Avascular necrosis of the hip Rheumatoid arthritis of the hip Younger than 18 years of age
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 |
|---|---|---|
| Direct anterior approach with capsulectomyDirect anterior approach with capsulectomy | Procedure or surgery | Surgical approach 1 |
| Direct anterior approach without capsulectomyDirect anterior approach without capsulectomy | Procedure or surgery | Surgical approach 2 |
Primary outcome
Hip flexion
Time frame: postoperative 4 months
1 secondary outcome
Visual analog scale-pain
Time frame: 4 months and 12 months post operative
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 26 Jan 2021.
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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.
John Masonis, MD principal investigator
OrthoCarolina, P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct anterior approach with capsulectomy and Direct anterior approach without capsulectomy in people with Total Hip Arthroplasty, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
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: finished, as of the sponsor's last update on 26 Jan 2021. 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 United States. 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?
Hip flexion (time frame: postoperative 4 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 26 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.