CoxarthritisPhase 1NCT02970253
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention
A Phase 1 study testing Capsular resection and Capsular retention in people with Coxarthritis, run by ZOL at 1 site in Belgium.
Trial summary
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus capsular flap retention. Prospective study design comparing clinical data in randomized THA patients who either had capsular resection or capsular flap retention. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coxarthritis
- What is being tested?
- Capsular resection and Capsular retention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2017to 31 Dec 2019
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- primary THA
Who cannot join
- neurologic disease
- painful contralateral THA
- severe back or knee pain
- rheumatology
Trial locations and contacts
1 site in 1 country.
About this study
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus capsular flap retention.
Prospective study design comparing clinical data in randomized THA patients who either had capsular resection or capsular flap retention.
- Conditions
- Coxarthritis
- Being tested
- Capsular resection, Capsular retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsular resectionProcedure or surgery
Capsular resection
Capsular retentionProcedure or surgery
Capsular retention
| Study group | Role | What they receive |
|---|---|---|
| Capsular resection | Active comparator | Capsular resection Receives: Procedure: Capsular resection |
| Capsular retention | Active comparator | Capsular retention Receives: Procedure: Capsular retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical data will be measured with scoring list HHS (Harris Hip Score).
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list HHS (Harris Hip Score).
Measured: One year
Clinical data will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).
Measured: One year
Clinical data will be measured with scoring list UCLA (University of California Los Angles activity score).
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list UCLA ((University of California Los Angles activity score).
Measured: One year
Clinical data will be measured with scoring list HOOS (Hip dysfunction and Osteoarthritis Outcome Score).
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring lists HOOS (Hip dysfunction and Osteoarthritis Outcome Score).
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 posted21 Nov 2016 (estimated)
- Study start1 Nov 2017
- Primary completion11 Nov 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthritisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZOL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Vanbiervliet, ZOL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970253
- Sponsor's protocol ID
- 16/076U
- Status last verified
- Feb 2020
- First submitted
- 3 Nov 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention
- ClinicalTrials.gov ID
- NCT02970253
- Acronym / sponsor ID
- 16/076U
- Conditions
- Coxarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- ZOLUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 11 Nov 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Nov 2016 (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.
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus capsular flap retention.
Prospective study design comparing clinical data in randomized THA patients who either had capsular resection or capsular flap retention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsular resection | Active comparator | Procedure: Capsular resectionCapsular resection |
| Capsular retention | Active comparator | Procedure: Capsular retentionCapsular retention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary THA
Key exclusion criteria (4 listed)
- neurologic disease
- painful contralateral THA
- severe back or knee pain
- rheumatology
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 |
|---|---|---|
| Capsular resectionCapsular resection | Procedure or surgery | Capsular resection |
| Capsular retentionCapsular retention | Procedure or surgery | Capsular retention |
Primary outcome
Clinical data will be measured with scoring list HHS (Harris Hip Score).
Time frame: One year
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list HHS (Harris Hip Score).
Clinical data will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).
Time frame: One year
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).
Clinical data will be measured with scoring list UCLA (University of California Los Angles activity score).
Time frame: One year
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list UCLA ((University of California Los Angles activity score).
Clinical data will be measured with scoring list HOOS (Hip dysfunction and Osteoarthritis Outcome Score).
Time frame: One year
Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring lists HOOS (Hip dysfunction and Osteoarthritis Outcome Score).
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 11 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capsular resection and Capsular retention in people with Coxarthritis, run by ZOL at 1 site in Belgium.
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 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: finished, as of the sponsor's last update on 11 Feb 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 Belgium. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical data will be measured with scoring list HHS (Harris Hip Score). (time frame: One year). The study lists 4 primary outcomes in all. 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 11 Feb 2020.