Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Injuries; Musculoskeletal Abnormalities
• Intervention / Treatment: Procedure: physiotherapy; Procedure: arthroscopy

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 Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Axel Öhlin, MD, PhD; Phone Number: 00460313430752; Email: axel.ohlin@gmail.com
• Study Contact Backup: Name: Mikael Sansone, MD, PhD; Phone Number: 00460313430336; Email: mikael.sansone@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 41346
    • Not yet recruiting
    • GHP Ortho Center Göteborg
    • Contact: Mattias Ahldén, MD, PhD
  • Gothenburg, Sweden, 41676
    • Recruiting
    • University of Gothenburg
    • Contact: Axel Öhlin, MD, PhD; Phone Number: 0046 0313430752; Email: axel.ohlin@gmail.com
  • Stockholm, Sweden, 11428
    • Not yet recruiting
    • Capio Artro Clinic
    • Contact: Anders Stålman, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: non-surgical treatment; All participants will undergo 6 months of non-surgical treatment.	Procedure: physiotherapy; Six months physiotherapy aimed at hip stability.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	24 Months
Type and Number of Adverse Events at 24 Months	Adverse events collected via phone interview.	24 Months
Single Question "Satisfied with Treatment?" at 24 Months	Participant-reported satisfaction with treatment (yes/no).	24 Months

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Stanford University; The Gothenburg Society of Medicine
• Investigators: Study Director: Mikael Sansone, MD, PhD, Göteborg University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2021
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: physiotherapy; arthroscopy
• Additional Relevant MeSH Terms: Wounds and Injuries; Congenital Abnormalities; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities
• Other Study ID Numbers: Hip Microinstability Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No