Musculoskeletal AbnormalitiesNCT04934462
Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability
A study testing physiotherapy and arthroscopy in people with Musculoskeletal Abnormalities and Hip Injuries, run by Göteborg University at 3 sites in Sweden.
Trial summary
Microinstability of the hip joint is an important cause of hip pain and reduced hip function in young and active individuals. Hip microinstability is due to extraphysiologic hip motion and could be secondary to acetabular dysplasia, connective tissue disorder, macrotrauma, microtrauma, iatrogenic- and idiopathic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Abnormalities, Hip Injuries
- What is being tested?
- physiotherapy and arthroscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesSweden
- Study dates
- 26 Nov 2021to Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip microinstability
- Minimum 18 years old
Who cannot join
- Hip osteoarthritis
- Severe hip dysplasia
- Perthes disease or avascular necrosis of the femoral head
- Previous surgery to the hip joint
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Not yet recruiting
GHP Ortho Center Göteborg
Gothenburg, 41346
Mattias Ahldén, MD, PhD
- Recruiting
University of Gothenburg
Gothenburg, 41676
Axel Öhlin, MD, PhD, 0313430752 ext. 0046, axel.ohlin@gmail.com
- Not yet recruiting
Capio Artro Clinic
Stockholm, 11428
Anders Stålman, MD, PhD
About this study
Official title: Prospective Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability
Microinstability of the hip joint is an important cause of hip pain and reduced hip function in young and active individuals. Hip microinstability is due to extraphysiologic hip motion and could be secondary to acetabular dysplasia, connective tissue disorder, macrotrauma, microtrauma, iatrogenic- and idiopathic causes. Treatment for hip microinstability is initiated with non-surgical treatment consisting of physiotherapy aimed mainly at stability. If non-surgical treatment fails, surgery with arthroscopic plication of the hip joint capsule is the preferred method. This study evaluates non-surgical and arthroscopic treatment for hip microinstability regarding hip function and adverse events.
Read the detailed description
This is a prospective cohort study evaluating 26 participants above 18 years of age undergoing non-surgical and surgical treatment for microinstability of the hip joint. Participants with findings on physical examination and imaging suggestive of hip microinstability will undergo six months of physiotherapy aimed at stabilizing the hip joint. If non-surgical treatment fails, a diagnostic hip arthroscopy will be performed, and if hip microinstability is confirmed, the participants will undergo a plication of the hip joint capsule. Participants will be evaluated with Patient-Reported Outcome Scores (PROMs) and strength- and function tests at time of enrollment and at 6-, 12- and 24 months following treatment. The primary outcome is hip function determined by PROMs and strength- and function tests. Secondary outcomes include Health-Related Quality of Life (HRQL), sport activity level and adverse events.
- Conditions
- Musculoskeletal Abnormalities, Hip Injuries
- Being tested
- physiotherapy, arthroscopy
- Keywords
- arthroscopy, physiotherapy
- Medical subject headings
- Musculoskeletal Abnormalities, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyProcedure or surgery
Six months physiotherapy aimed at hip stability.
arthroscopyProcedure or surgery
Arthroscopic plication of hip joint capsule.
| Study group | Role | What they receive |
|---|---|---|
| non-surgical treatment | Other | All participants will undergo 6 months of non-surgical treatment. Receives: Procedure: physiotherapy |
| arthroscopic treatment | Other | Those participants with failed non-surgical treatment at 6 months will undergo arthroscopic treatment. Receives: Procedure: physiotherapy; Procedure: arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Hip Function on the International Hip Outcome Tool (iHOT-12) at 24 Months
Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).
Measured: 24 Months
Mean Change from Baseline in Hip Function on the Copenhagen Hip and Groin Outcome Score (HAGOS) at 24 Months
Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).
Measured: 24 Months
Mean Change from Baseline in Maximal Isometric Hip Muscle Force in Newton at 24 Months
Maximal hip isometric muscle force will be assessed using a dynamometer (Hoggan MicroFET2, Hoggan, Scientific L.L.C., Salt Lake City, USA) for hip flexion, adduction, abduction, and extension. The maximal developed force in Newton will be recorded. Higher Newton value means a better outcome.
Measured: 24 Months
Mean Change from Baseline in Hop Performance at 24 Months
Hop performance will be measured with 3 single-leg hops: vertical hop (Muscle lab, Ergotest Technology, Oslo, Norway), hop for distance and a 30-second side-hop test. Each hop test is performed with the patients holding their hands behind their back. For the vertical hop, the time from take-off to landing is converted into hop height in centimeters. In the hop for distance test, the distance between top of the toes at take-off to heel at landing is measured in centimeters. For the 30 second side hop test, one trial per leg is allowed, where the patient is instructed to hop as many times as possible over 2 lines 40 centimeters apart. The number of hops is recorded. Higher height, longer distance and higher number of hops means a better outcome.
Measured: 24 Months
Secondary outcomes (4)
Mean Change from Baseline in Hip Function on the EuroQoL-5 Dimensions (EQ-5D) at 24 Months
Participant-reported health-related quality of life. Minimum score 0, maximum score 1 (higher score mean a higher health-related quality of life).
Measured: 24 Months
Mean Change from Baseline in Hip Function on the Hip Sport Activity Scale (HSAS) at 24 Months
Participant-reported sport activity level. Minimum score 0, maximum score 8 (higher score mean a higher sport activity level).
Measured: 24 Months
Type and Number of Adverse Events at 24 Months
Adverse events collected via phone interview.
Measured: 24 Months
Single Question "Satisfied with Treatment?" at 24 Months
Participant-reported satisfaction with treatment (yes/no).
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start26 Nov 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Society of Medicine, Stanford University
- Responsible party
- Sponsor
- Investigators
- Mikael Sansone, MD, PhD, Study director, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934462
- Sponsor's protocol ID
- Hip Microinstability Study
- Status last verified
- Mar 2025
- First submitted
- 31 May 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohlin A, Senorski EH, Sansone M, Leff G, Desai N, Lindman I, Ayeni OR, Safran MR. Protocol for a multicenter prospective cohort study evaluating arthroscopic and non-surgical treatment for microinstability of the hip joint. BMC Musculoskelet Disord. 2022 Mar 31;23(1):309. doi: 10.1186/s12891-022-05269-x.
PubMed 35361185
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability
- ClinicalTrials.gov ID
- NCT04934462
- Acronym / sponsor ID
- Hip Microinstability Study
- Conditions
- Musculoskeletal Abnormalities, Hip Injuries
- Keywords
- arthroscopy, physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Swedish Society of Medicine, Stanford University
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 22 Jun 2021 (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.
Microinstability of the hip joint is an important cause of hip pain and reduced hip function in young and active individuals. Hip microinstability is due to extraphysiologic hip motion and could be secondary to acetabular dysplasia, connective tissue disorder, macrotrauma, microtrauma, iatrogenic- and idiopathic causes. Treatment for hip microinstability is initiated with non-surgical treatment consisting of physiotherapy aimed mainly at stability. If non-surgical treatment fails, surgery with arthroscopic plication of the hip joint capsule is the preferred method. This study evaluates non-surgical and arthroscopic treatment for hip microinstability regarding hip function and adverse events.
Detailed description
This is a prospective cohort study evaluating 26 participants above 18 years of age undergoing non-surgical and surgical treatment for microinstability of the hip joint. Participants with findings on physical examination and imaging suggestive of hip microinstability will undergo six months of physiotherapy aimed at stabilizing the hip joint. If non-surgical treatment fails, a diagnostic hip arthroscopy will be performed, and if hip microinstability is confirmed, the participants will undergo a plication of the hip joint capsule. Participants will be evaluated with Patient-Reported Outcome Scores (PROMs) and strength- and function tests at time of enrollment and at 6-, 12- and 24 months following treatment. The primary outcome is hip function determined by PROMs and strength- and function tests. Secondary outcomes include Health-Related Quality of Life (HRQL), sport activity level and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-surgical treatment | Other | Procedure: physiotherapyAll participants will undergo 6 months of non-surgical treatment. |
| arthroscopic treatment | Other | Procedure: physiotherapy, Procedure: arthroscopyThose participants with failed non-surgical treatment at 6 months will undergo arthroscopic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hip microinstability
- Minimum 18 years old
Key exclusion criteria (4 listed)
- Hip osteoarthritis
- Severe hip dysplasia
- Perthes disease or avascular necrosis of the femoral head
- Previous surgery to the hip joint
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 |
|---|---|---|
| physiotherapySix months physiotherapy aimed at hip stability. | Procedure or surgery | arthroscopic treatment, non-surgical treatment |
| arthroscopyArthroscopic plication of hip joint capsule. | Procedure or surgery | arthroscopic treatment |
Primary outcome
Mean Change from Baseline in Hip Function on the International Hip Outcome Tool (iHOT-12) at 24 Months
Time frame: 24 Months
Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).
Mean Change from Baseline in Hip Function on the Copenhagen Hip and Groin Outcome Score (HAGOS) at 24 Months
Time frame: 24 Months
Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).
Mean Change from Baseline in Maximal Isometric Hip Muscle Force in Newton at 24 Months
Time frame: 24 Months
Maximal hip isometric muscle force will be assessed using a dynamometer (Hoggan MicroFET2, Hoggan, Scientific L.L.C., Salt Lake City, USA) for hip flexion, adduction, abduction, and extension. The maximal developed force in Newton will be recorded. Higher Newton value means a better outcome.
Mean Change from Baseline in Hop Performance at 24 Months
Time frame: 24 Months
Hop performance will be measured with 3 single-leg hops: vertical hop (Muscle lab, Ergotest Technology, Oslo, Norway), hop for distance and a 30-second side-hop test. Each hop test is performed with the patients holding their hands behind their back. For the vertical hop, the time from take-off to landing is converted into hop height in centimeters. In the hop for distance test, the distance between top of the toes at take-off to heel at landing is measured in centimeters. For the 30 second side hop test, one trial per leg is allowed, where the patient is instructed to hop as many times as possible over 2 lines 40 centimeters apart. The number of hops is recorded. Higher height, longer distance and higher number of hops means a better outcome.
4 secondary outcomes
Mean Change from Baseline in Hip Function on the EuroQoL-5 Dimensions (EQ-5D) at 24 Months
Time frame: 24 Months
Mean Change from Baseline in Hip Function on the Hip Sport Activity Scale (HSAS) at 24 Months
Time frame: 24 Months
Type and Number of Adverse Events at 24 Months
Time frame: 24 Months
Single Question "Satisfied with Treatment?" at 24 Months
Time frame: 24 Months
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 12 Mar 2025.
- Derived from this study: PubMed 35361185Ohlin A, Senorski EH, Sansone M, Leff G, Desai N, Lindman I, Ayeni OR, Safran MR. Protocol for a multicenter prospective cohort study evaluating arthroscopic and non-surgical treatment for microinstability of the hip joint. BMC Musculoskelet Disord. 2022 Mar 31;23(1):309. doi: 10.1186/s12891-022-05269-x.
- Individual participant dataSharing planned: No
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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.
Mikael Sansone, MD, PhD study director
Göteborg University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy and arthroscopy in people with Musculoskeletal Abnormalities and Hip Injuries, run by Göteborg University at 3 sites in Sweden.
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 2 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Contact Axel Öhlin, MD, PhD (00460313430752, axel.ohlin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Hip Function on the International Hip Outcome Tool (iHOT-12) at 24 Months (time frame: 24 Months). 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?
On the ClinicalTrials.gov record for NCT04934462, which also lists 1 linked publication.
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 12 Mar 2025.