Rupture of Hip Abductor Tendon (Disorder)NCT06398015
Hip Abductor Tendon Repair Versus Sham Surgery
A study testing Surgical reconstruction of hip abductor tendon tear in people with Rupture of Hip Abductor Tendon (Disorder), run by Horsens Hospital at 1 site in Denmark.
Trial summary
This study will examine the effectiveness of open surgical reconstruction in the treatment of patients with hip abductor tendon tears. Patients will be randomly allocated to either the open surgical reconstruction or to a open surgical sham procedure. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Rupture of Hip Abductor Tendon (Disorder)
- What is being tested?
- Surgical reconstruction of hip abductor tendon tear
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2024to 26 Jun 2026
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an MRI verified hip abductor tendon pathology
- Age 30 years or above
- Lateral hip pain for more than 12 months
- Ability to understand written and verbal Danish
Who cannot join
- Previous hip joint replacement, pelvic osteomies, hip abductor tendon surgery, femoral nailing or iliotibial band surgery
- Pregnancy
- Osteoarthritis of the hip joint on the affected side (Kellgren Lawrence grade +2)
- Rheumatoid disorders
- Inability to attend planned follow-up visits
- Having an ongoing occupational injury insurance case
- Expected lack of compliance due to cognitive issues, alcohol, or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Surgical Reconstruction Versus Open Sham Surgery in the Treatment of Hip Abductor Tendon Tears; A Double Blinded, Randomized Controlled Trial
This study will examine the effectiveness of open surgical reconstruction in the treatment of patients with hip abductor tendon tears. Patients will be randomly allocated to either the open surgical reconstruction or to a open surgical sham procedure. The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score (HAGOS), which will be conducted pre-surgery and at three and six months post-surgery. The six-month follow-up is the primary endpoint.
Read the detailed description
This is a study protocol for a Good Clinical Practice-monitored, double-blinded, randomized, controlled superiority trial with two groups, where the primary endpoint is differences in changes in lateral hip pain 6 months post-surgery. If included in the study, patients will be randomly allocated to one of the two arms:
- Open surgical reconstruction of the hip abductor tear (rHAT-group)
- Sham surgery (SHAM-group)
Patients will be allocated with a 1:1 ratio using permuted blocks with random varying sizes of 4, 6, and 8. An interim analysis will be performed when 8 patients in each group have completed the primary outcome assessment at 6 months.
Post-surgery, the patients in both groups will be guided and instructed in exercises according to their pain levels and functional capacity by an experienced physiotherapist blinded to the allocation. The first 6 post-surgery weeks, rehabilitation is home-based. After the 6-week follow-up, the patients will be referred to further rehabilitation in their home municipality (current standard practice).
The patients will be assessed pre-surgery, at 3 months post-surgery, and at the final follow-up at 6 months post-surgery. A physiotherapist blinded to the allocation will test the patients at the abovementioned timepoints.
In the trial paper all outcomes conducted will be published. That is, the primary outcome and the following secondary outcomes: The remaining five subscales of the revised HAGOS questionnaire (symptoms, function in daily living, function in sport and recreation, participation in physical activity, quality of life), Oxford Hip Score (OHS), European Questionnaire-5 Dimension (EQ-5D-5L and EQ-VAS), Global Rating of Change (GroC), Lateral hip pain on a numerical rating scale (NRS), The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G), isometric hip abduction muscle strength, functional capacity by a 30 second Chair Stand Test (30s-CST).
The primary aim is to evaluate between-group changes on hip pain based on the subscale "pain" from the patient-reported outcome measure the revised Copenhagen Hip And Groin Outcome Score (HAGOS) from pre-surgery to 6 months post-surgery.
Primarily The primary hypothesis: The score in the subscale "pain" on the revised HAGOS will increase more in the intervention group compared to the control group, 6 months post-surgery.
A full study protocol will be published and made available.
- Being tested
- Surgical reconstruction of hip abductor tendon tear, Sham surgery of hip abductor tendon tear
- Keywords
- orthopedics, hip injuries, rehabilitation, sham surgery, lateral hip pain, hip abductor tendon tear
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical reconstruction of hip abductor tendon tearProcedure or surgery
If the patient is allocated to surgical reconstruction, the incision from the sham surgery is continued into the iliotibial band (ITB) and down to the hip abductor tendon complex/greater trochanter. A standardized reconstruction of the HAT with bone anchors is then performed.
This standardized procedure has been used by the surgeons for the last 6 years. The ITB is then closed with looped suture, the subcutaneous tissue sutured with standard resorbable single sutures, the skin stapled and a standard wound dressing is applied.
Sham surgery of hip abductor tendon tearProcedure or surgery
If the patient is allocated to sham surgery, the incision will only include the skin and subcutaneous tissue. Subsequently, the subcutaneous tissue will be sutured with standard resorbable single sutures, the skin stapled and a standard wound dressing applied. The patient will be kept in general anesthesia for 10 minutes after the procedure is finalized to mimic a true intervention (to hinder staff or relatives to comment on the duration of the procedure). The normal standard procedure takes approximately 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| rHat-group | Experimental | Surgical reconstruction of hip abductor tendon tear Receives: Procedure: Surgical reconstruction of hip abductor tendon tear |
| SHAM-group | Sham comparator | Sham surgery of hip abductor tendon tear Receives: Procedure: Sham surgery of hip abductor tendon tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
The subscale "pain" on HAGOS measures the patients perception of hip and/or groin pain. It consist of ten items. A score from 0 to 100 is calculated, where a higher score is indicating lower pain.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Secondary outcomes (12)
Differences in changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
The subscale "symptoms" on HAGOS measures the patients perception of hip and/or groin pain. It consist of seven items. A score from 0 to 100 is calculated, where a higher score is indicating lower symptoms.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
The subscale "ADL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher function.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported physical function in sport and recreational activities (sport/recreation) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
The subscale "sport/recreation" on HAGOS measures the patients perception of hip and/or groin pain. It consist of eight items. A score from 0 to 100 is calculated, where a higher score is indicating higher function.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
The subscale "PA" on HAGOS measures the patients perception of hip and/or groin pain. It consist of two items. A score from 0 to 100 is calculated, where a higher score is indicating higher ability to participate in physical activity.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
The subscale "QOL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher quality of life.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in the patient-reported outcome measure Oxford Hip Score (continuous data)
Oxford Hip Score (OHS), which consists of 12items. OHS is developed and validated for patients undergoing total hip replacements to access pain and function. It is a composite score ranging from 0 (worst) to 48 (best).
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in the patient-reported outcome measure EQ-5D-5L (continuous data)
European Questionnaire-5 Dimensions (EQ-5D-5L and EQ-VAS) consists of five items and a visual analogue score (VAS), a vertical line on which the patients score their perception of their overall health from 0 to 100 (worst to best)
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Global Rating of Change (GRoC)
GRoC consists of a 11-point scale, where the patient rates the perceived overall change of the hip condition from "very much better" to "very much worse" . Responses on GRoC will be considered successful if patients scored "moderately better" to "very much better". Global improvement will be measured as the percentage of successful reports.
Measured: The outcome is conducted at 3- and 6-months post-surgery follow-up.
Differences in changes in lateral hip pain on a numerical pain rating scale (NRS)
Participants rate their pain on a scale from 0 (no pain) to 10 (worst imaginable). Participants will rate their average pain for the past 14 days during rest and activity.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data)
The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) is validated for patients with gluteal tendinopathy and measures the severity of disability related to the condition. VISA-G consist of eight items and appraise the pain in relation to gluteal tendinopathy by a score from 0-100, where a higher score will indicate lower pain and less disability.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes of maximal isometric hip abduction muscle strength (continuous data)
Maximal isometric hip abduction strength test measures the maximal voluntary isometric contraction in supine position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes of the number of repetitions of a 30 second sit to stand test (continuous data)
Number of repetitions (sits to stand) performed during 30 seconds on a chair with a seat height of 46 cm.
Measured: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 May 2024
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Why it stopped: None of the screened potential participants were interested in participating.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Hip Abductor Tendon (Disorder)Studies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horsens Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Jeppe Lange, Horsens Hospital
- Investigators
- Mathias Høgsholt, PT, PhD.st., Principal investigator, Horsens Regional Hospital; Aarhus UniversityJeppe Lange, MD, PhD, Study director, Horsens Regional Hospital; Aarhus UniversitySigne Kierkegaard-Brøchner, PhD, Study chair, Regionshospitalet HorsensKristian Thorborg, PhD, Study chair, Copenhagen University Hospital, HvidovreMarie Bagger Bohn, MD, PhD, Study chair, Regionshospitalet Horsens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398015
- Sponsor's protocol ID
- 1-16-02-128-24
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What data will be shared: All quantitative individual participant data collected during the trial, after deidentification, and according to current Danish Data Protection Regulation and GDPR. With whom will data be shared: Researchers who provide a methodologically sound proposal. For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trial: A Requirement of the ICMJE located at: https://www.icmje.org/news-and-editorials/data\_sharing\_june\_2017.pdf
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Surgical Reconstruction Versus Open Sham Surgery in the Treatment of Hip Abductor Tendon Tears; A Double Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06398015
- Acronym / sponsor ID
- 1-16-02-128-24
- Keywords
- orthopedics, hip injuries, rehabilitation, sham surgery, lateral hip pain, hip abductor tendon tear
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: None of the screened potential participants were interested in participating.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Horsens HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 1 May 2024 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 3 May 2024 (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.
This study will examine the effectiveness of open surgical reconstruction in the treatment of patients with hip abductor tendon tears. Patients will be randomly allocated to either the open surgical reconstruction or to a open surgical sham procedure. The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score (HAGOS), which will be conducted pre-surgery and at three and six months post-surgery. The six-month follow-up is the primary endpoint.
Detailed description
This is a study protocol for a Good Clinical Practice-monitored, double-blinded, randomized, controlled superiority trial with two groups, where the primary endpoint is differences in changes in lateral hip pain 6 months post-surgery. If included in the study, patients will be randomly allocated to one of the two arms:
- Open surgical reconstruction of the hip abductor tear (rHAT-group)
- Sham surgery (SHAM-group)
Patients will be allocated with a 1:1 ratio using permuted blocks with random varying sizes of 4, 6, and 8. An interim analysis will be performed when 8 patients in each group have completed the primary outcome assessment at 6 months.
Post-surgery, the patients in both groups will be guided and instructed in exercises according to their pain levels and functional capacity by an experienced physiotherapist blinded to the allocation. The first 6 post-surgery weeks, rehabilitation is home-based. After the 6-week follow-up, the patients will be referred to further rehabilitation in their home municipality (current standard practice).
The patients will be assessed pre-surgery, at 3 months post-surgery, and at the final follow-up at 6 months post-surgery. A physiotherapist blinded to the allocation will test the patients at the abovementioned timepoints.
In the trial paper all outcomes conducted will be published. That is, the primary outcome and the following secondary outcomes: The remaining five subscales of the revised HAGOS questionnaire (symptoms, function in daily living, function in sport and recreation, participation in physical activity, quality of life), Oxford Hip Score (OHS), European Questionnaire-5 Dimension (EQ-5D-5L and EQ-VAS), Global Rating of Change (GroC), Lateral hip pain on a numerical rating scale (NRS), The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G), isometric hip abduction muscle strength, functional capacity by a 30 second Chair Stand Test (30s-CST).
The primary aim is to evaluate between-group changes on hip pain based on the subscale "pain" from the patient-reported outcome measure the revised Copenhagen Hip And Groin Outcome Score (HAGOS) from pre-surgery to 6 months post-surgery.
Primarily The primary hypothesis: The score in the subscale "pain" on the revised HAGOS will increase more in the intervention group compared to the control group, 6 months post-surgery.
A full study protocol will be published and made available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rHat-group | Experimental | Procedure: Surgical reconstruction of hip abductor tendon tearSurgical reconstruction of hip abductor tendon tear |
| SHAM-group | Sham comparator | Procedure: Sham surgery of hip abductor tendon tearSham surgery of hip abductor tendon tear |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with an MRI verified hip abductor tendon pathology
- Age 30 years or above
- Lateral hip pain for more than 12 months
- Ability to understand written and verbal Danish
Key exclusion criteria (7 listed)
- Previous hip joint replacement, pelvic osteomies, hip abductor tendon surgery, femoral nailing or iliotibial band surgery
- Pregnancy
- Osteoarthritis of the hip joint on the affected side (Kellgren Lawrence grade +2)
- Rheumatoid disorders
- Inability to attend planned follow-up visits
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 |
|---|---|---|
| Surgical reconstruction of hip abductor tendon tearIf the patient is allocated to surgical reconstruction, the incision from the sham surgery is continued into the iliotibial band (ITB) and down to the hip abductor tendon complex/greater trochanter. A standardized reconstruction of the HAT with bone anchors is then performed. This standardized procedure has been used by the surgeons for the last 6 years. The ITB is then closed with looped suture, the subcutaneous tissue sutured with standard resorbable single sutures, the skin stapled and a standard wound dressing is applied. | Procedure or surgery | rHat-group |
| Sham surgery of hip abductor tendon tearIf the patient is allocated to sham surgery, the incision will only include the skin and subcutaneous tissue. Subsequently, the subcutaneous tissue will be sutured with standard resorbable single sutures, the skin stapled and a standard wound dressing applied. The patient will be kept in general anesthesia for 10 minutes after the procedure is finalized to mimic a true intervention (to hinder staff or relatives to comment on the duration of the procedure). The normal standard procedure takes approximately 40 minutes. | Procedure or surgery | SHAM-group |
Primary outcome
Differences in changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
The subscale "pain" on HAGOS measures the patients perception of hip and/or groin pain. It consist of ten items. A score from 0 to 100 is calculated, where a higher score is indicating lower pain.
12 secondary outcomes
Differences in changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported physical function in sport and recreational activities (sport/recreation) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in the patient-reported outcome measure Oxford Hip Score (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in the patient-reported outcome measure EQ-5D-5L (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Global Rating of Change (GRoC)
Time frame: The outcome is conducted at 3- and 6-months post-surgery follow-up.
Differences in changes in lateral hip pain on a numerical pain rating scale (NRS)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes of maximal isometric hip abduction muscle strength (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes of the number of repetitions of a 30 second sit to stand test (continuous data)
Time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. What data will be shared: All quantitative individual participant data collected during the trial, after deidentification, and according to current Danish Data Protection Regulation and GDPR. With whom will data be shared: Researchers who provide a methodologically sound proposal. For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trial: A Requirement of the ICMJE located at: https://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf
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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.
Mathias Høgsholt, PT, PhD.st. principal investigator
Horsens Regional Hospital; Aarhus University
Jeppe Lange, MD, PhD study director
Horsens Regional Hospital; Aarhus University
Signe Kierkegaard-Brøchner, PhD study chair
Regionshospitalet Horsens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical reconstruction of hip abductor tendon tear in people with Rupture of Hip Abductor Tendon (Disorder), run by Horsens 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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Jun 2026. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Differences in changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) (time frame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.). 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 Jun 2026.