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NCT Number: NCT04934462

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.

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Key information

Conditions

Musculoskeletal Abnormalities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hip Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHP Ortho Center Göteborg, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physiotherapy

Procedure

Six months physiotherapy aimed at hip stability.

Arthroscopy

Procedure

Arthroscopic plication of hip joint capsule.

Primary outcomes

  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 outcomes

  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).

Study contacts

Contact information is provided by the study sponsor or research team.

Axel Öhlin, MD, PhD

CONTACT

[email protected]

00460313430752

Mikael Sansone, MD, PhD

CONTACT

[email protected]

00460313430336

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Stanford University
  • The Swedish Society of Medicine

Registry information

Official study title

Prospective Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2021
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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