Hip InjuriesNCT03158454
Capsula Closure vs. Non-Capsula Closure: Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)
A study testing Capsula Closure and Non-Capsula Closure in people with Hip Injuries, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate whether patients undergoing surgical treatment (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of higher scores in validated patient reported outcome measurements, compared to a Group of patients with FAI syndrome where the capsule… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hip Injuries
- What is being tested?
- Capsula Closure and Non-Capsula Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jun 2017to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Radiological and symptomatic Femoroacetabular Impingement, where surgery is indicated. Preoperatively a minimum of 3 months of relevant physiotherapeutic treatment should have been performed.
Who cannot join
- Previous hip surgery in either hip
- Malignant disease
- Recent hip or pelvic fractures
- Arthritic disease
- Hip joint dysplasia
- Legg-Calvé-Perthes
Show all 9Show fewer
- Slipped Capital Femoris Epiphysis
- Recent (within 6 weeks) medical treatment with corticosteroids
- Language problems of any kind
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capsula Closure Versus Non-Capsula Closure During Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)
The purpose of this study is to investigate whether patients undergoing surgical treatment (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of higher scores in validated patient reported outcome measurements, compared to a Group of patients with FAI syndrome where the capsule is left open at the end of the surgical procedure.
- Conditions
- Hip Injuries
- Being tested
- Capsula Closure, Non-Capsula Closure
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsula ClosureProcedure or surgery
The capsular closure is performed with a minimum of two vicryl # 2 resorbable sutures
Non-Capsula ClosureProcedure or surgery
No capsular closure procedure is performed.
| Study group | Role | What they receive |
|---|---|---|
| Capsula Closure | Other | Not described Receives: Procedure: Capsula Closure |
| Non-Capsula Closure | Other | Not described Receives: Procedure: Non-Capsula Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported outcome scores (Hagos)
Copenhagen Hip and Groin Outcome Score - Questionnaire - Hip-function Score (0-100)
Measured: From baseline to 2 year after the operation
Secondary outcomes (4)
Change in patient reported outcome scores (Ihot12)
Questionnaire - Hip-function Score (0-100)
Measured: From baseline to 2 year after the operation
Change in patient reported outcome scores (NRS)
Questionnaire - Pain-Score (0-10)
Measured: From baseline to 2 year after the operation
Change in patient reported outcome scores (EQ5D
Questionnaire - health outcome score.
Measured: From baseline to 2 year after the operation
Reoperation
revision hip arthroscopy/THA/other)
Measured: Up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start15 Jun 2017
- Primary completion1 Dec 2022
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158454
- Sponsor's protocol ID
- Danish EC 1-10-72-279-16
- Status last verified
- Sep 2025
- First submitted
- 15 May 2017
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mygind-Klavsen B, Kraemer O, Lund B, Krogsgaard M, Holmich P, Lind M, Nielsen TG, Miller LL, Philippon M, Dippmann C. Interportal Capsulotomy Closure Does Not Improve the Results After Hip Arthroscopy at 1-Year Follow-up: A Prospective Randomized Controlled Study. Orthop J Sports Med. 2025 Sep 5;13(9):23259671251363604. doi: 10.1177/23259671251363604. eCollection 2025 Sep.
PubMed 40917599Dippmann C, Kraemer O, Lund B, Krogsgaard M, Holmich P, Lind M, Briggs K, Philippon M, Mygind-Klavsen B. Multicentre study on capsular closure versus non-capsular closure during hip arthroscopy in Danish patients with femoroacetabular impingement (FAI): protocol for a randomised controlled trial. BMJ Open. 2018 Feb 10;8(2):e019176. doi: 10.1136/bmjopen-2017-019176.
PubMed 29440159
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsula Closure Versus Non-Capsula Closure During Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)
- ClinicalTrials.gov ID
- NCT03158454
- Acronym / sponsor ID
- Danish EC 1-10-72-279-16
- Conditions
- Hip Injuries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 May 2017 (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.
The purpose of this study is to investigate whether patients undergoing surgical treatment (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of higher scores in validated patient reported outcome measurements, compared to a Group of patients with FAI syndrome where the capsule is left open at the end of the surgical procedure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsula Closure | Other | Procedure: Capsula Closure |
| Non-Capsula Closure | Other | Procedure: Non-Capsula Closure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Radiological and symptomatic Femoroacetabular Impingement, where surgery is indicated. Preoperatively a minimum of 3 months of relevant physiotherapeutic treatment should have been performed.
Key exclusion criteria (9 listed)
- Previous hip surgery in either hip
- Malignant disease
- Recent hip or pelvic fractures
- Arthritic disease
- Hip joint dysplasia
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 |
|---|---|---|
| Capsula ClosureThe capsular closure is performed with a minimum of two vicryl # 2 resorbable sutures | Procedure or surgery | Capsula Closure |
| Non-Capsula ClosureNo capsular closure procedure is performed. | Procedure or surgery | Non-Capsula Closure |
Primary outcome
Change in patient reported outcome scores (Hagos)
Time frame: From baseline to 2 year after the operation
Copenhagen Hip and Groin Outcome Score - Questionnaire - Hip-function Score (0-100)
4 secondary outcomes
Change in patient reported outcome scores (Ihot12)
Time frame: From baseline to 2 year after the operation
Change in patient reported outcome scores (NRS)
Time frame: From baseline to 2 year after the operation
Change in patient reported outcome scores (EQ5D
Time frame: From baseline to 2 year after the operation
Reoperation
Time frame: Up to 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 40917599Mygind-Klavsen B, Kraemer O, Lund B, Krogsgaard M, Holmich P, Lind M, Nielsen TG, Miller LL, Philippon M, Dippmann C. Interportal Capsulotomy Closure Does Not Improve the Results After Hip Arthroscopy at 1-Year Follow-up: A Prospective Randomized Controlled Study. Orthop J Sports Med. 2025 Sep 5;13(9):23259671251363604. doi: 10.1177/23259671251363604. eCollection 2025 Sep.
- Derived from this study: PubMed 29440159Dippmann C, Kraemer O, Lund B, Krogsgaard M, Holmich P, Lind M, Briggs K, Philippon M, Mygind-Klavsen B. Multicentre study on capsular closure versus non-capsular closure during hip arthroscopy in Danish patients with femoroacetabular impingement (FAI): protocol for a randomised controlled trial. BMJ Open. 2018 Feb 10;8(2):e019176. doi: 10.1136/bmjopen-2017-019176.
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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 study testing Capsula Closure and Non-Capsula Closure in people with Hip Injuries, run by Aarhus University Hospital at 1 site in Denmark.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in patient reported outcome scores (Hagos) (time frame: From baseline to 2 year after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03158454, which also lists 2 linked publications.
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 1 Oct 2025.