Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability

NCT04934462 | Recruiting

• 1 other identifier: Hip Microinstability Study
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Musculoskeletal Abnormalities; Hip Injuries

Keywords

arthroscopy; physiotherapy

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  24 Months

Secondary Outcomes (4)

• Mean Change from Baseline in Hip Function on the EuroQoL-5 Dimensions (EQ-5D) at 24 Months

  24 Months

• Mean Change from Baseline in Hip Function on the Hip Sport Activity Scale (HSAS) at 24 Months

  24 Months

• Type and Number of Adverse Events at 24 Months

  24 Months

• Single Question "Satisfied with Treatment?" at 24 Months

  24 Months

Study Arms (2)

non-surgical treatment

OTHER

All participants will undergo 6 months of non-surgical treatment.

Procedure: physiotherapy

arthroscopic treatment

OTHER

Those participants with failed non-surgical treatment at 6 months will undergo arthroscopic treatment.

Procedure: physiotherapy; Procedure: arthroscopy

Interventions

physiotherapy PROCEDURE

Six months physiotherapy aimed at hip stability.

arthroscopic treatment; non-surgical treatment

arthroscopy PROCEDURE

Arthroscopic plication of hip joint capsule.

arthroscopic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hip microinstability
• Minimum 18 years old

You may not qualify if:

• Hip osteoarthritis
• Severe hip dysplasia
• Perthes disease or avascular necrosis of the femoral head
• Previous surgery to the hip joint

Sponsors & Collaborators

• Göteborg University: lead
• The Swedish Society of Medicine: collaborator
• Stanford University: collaborator

Study Sites (3)

GHP Ortho Center Göteborg

Gothenburg, 41346, Sweden

NOT YET RECRUITING

University of Gothenburg

Gothenburg, 41676, Sweden

RECRUITING

Capio Artro Clinic

Stockholm, 11428, Sweden

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 35361185 DERIVED

MeSH Terms

Conditions

Musculoskeletal Abnormalities; Hip Injuries

Interventions

Physical Therapy Modalities; Arthroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• Mikael Sansone, MD, PhD

  Göteborg University

  STUDY DIRECTOR

Central Study Contacts

Axel Öhlin, MD, PhD

CONTACT

00460313430752; axel.ohlin@gmail.com

Mikael Sansone, MD, PhD

CONTACT

00460313430336; mikael.sansone@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 22, 2021
• Study Start: November 26, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)