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Trial record 1 of 1 for:    hip microinstability
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Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability

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ClinicalTrials.gov Identifier: NCT04934462
Recruitment Status : Recruiting
First Posted : June 22, 2021
Last Update Posted : March 16, 2022
Sponsor:
Collaborators:
The Gothenburg Society of Medicine
Stanford University
Information provided by (Responsible Party):
Göteborg University

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Abnormalities Hip Injuries Procedure: physiotherapy Procedure: arthroscopy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability
Actual Study Start Date : November 26, 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025
Arms and Interventions
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Arm Intervention/treatment
non-surgical treatment
All participants will undergo 6 months of non-surgical treatment.
 Procedure: physiotherapy
Six months physiotherapy aimed at hip stability.
arthroscopic treatment
Those participants with failed non-surgical treatment at 6 months will undergo arthroscopic treatment.
 Procedure: physiotherapy
Six months physiotherapy aimed at hip stability.

Procedure: arthroscopy
Arthroscopic plication of hip joint capsule.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Mean Change from Baseline in Hip Function on the EuroQoL-5 Dimensions (EQ-5D) at 24 Months [ Time Frame: 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).

  2. Mean Change from Baseline in Hip Function on the Hip Sport Activity Scale (HSAS) at 24 Months [ Time Frame: 24 Months ]
    Participant-reported sport activity level. Minimum score 0, maximum score 8 (higher score mean a higher sport activity level).

  3. Type and Number of Adverse Events at 24 Months [ Time Frame: 24 Months ]
    Adverse events collected via phone interview.

  4. Single Question "Satisfied with Treatment?" at 24 Months [ Time Frame: 24 Months ]
    Participant-reported satisfaction with treatment (yes/no).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hip microinstability
  • Minimum 18 years old

Exclusion Criteria:

  • Hip osteoarthritis
  • Severe hip dysplasia
  • Perthes disease or avascular necrosis of the femoral head
  • Previous surgery to the hip joint
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04934462


Contacts
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Contact: Axel Öhlin, MD, PhD 00460313430752 axel.ohlin@gmail.com
Contact: Mikael Sansone, MD, PhD 00460313430336 mikael.sansone@vgregion.se

Locations
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Sweden
GHP Ortho Center Göteborg Not yet recruiting
Gothenburg, Sweden, 41346
Contact: Mattias Ahldén, MD, PhD         
University of Gothenburg Recruiting
Gothenburg, Sweden, 41676
Contact: Axel Öhlin, MD, PhD    0313430752 ext 0046    axel.ohlin@gmail.com   
Capio Artro Clinic Not yet recruiting
Stockholm, Sweden, 11428
Contact: Anders Stålman, MD, PhD         
Sponsors and Collaborators
Göteborg University
The Gothenburg Society of Medicine
Stanford University
Investigators
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Study Director: Mikael Sansone, MD, PhD Göteborg University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT04934462    
Other Study ID Numbers: Hip Microinstability Study
First Posted: June 22, 2021    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
arthroscopy
physiotherapy
Additional relevant MeSH terms:
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Musculoskeletal Abnormalities
Hip Injuries
Congenital Abnormalities
Wounds and Injuries
Musculoskeletal Diseases