Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability

Hip Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934462
• Other study ID #: Hip Microinstability Study
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2021
• Est. completion date: January 2025

Study information

• Verified date: March 2022
• Source: Göteborg University
• Contact: Axel Öhlin, MD, PhD
• Phone: 00460313430752
• Email: axel.ohlin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Injuries
• Musculoskeletal Abnormalities

Intervention

Procedure:
• physiotherapy
Six months physiotherapy aimed at hip stability.
• arthroscopy
Arthroscopic plication of hip joint capsule.

Locations

Country	Name	City	State
Sweden	GHP Ortho Center Göteborg	Gothenburg
Sweden	University of Gothenburg	Gothenburg
Sweden	Capio Artro Clinic	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Stanford University, The Gothenburg Society of Medicine

Country where clinical trial is conducted

Sweden, 

Outcome

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