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Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability

Primary Purpose

Musculoskeletal Abnormalities, Hip Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
physiotherapy
arthroscopy
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Abnormalities focused on measuring arthroscopy, physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GHP Ortho Center Göteborg
  • University of GothenburgRecruiting
  • Capio Artro Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

non-surgical treatment

arthroscopic treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
May 31, 2021
Last Updated
March 15, 2022
Sponsor
Göteborg University
Collaborators
The Gothenburg Society of Medicine, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04934462
Brief Title
Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability
Official Title
Prospective Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 26, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
The Gothenburg Society of Medicine, Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Abnormalities, Hip Injuries
Keywords
arthroscopy, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non-surgical treatment
Arm Type
Other
Arm Description
All participants will undergo 6 months of non-surgical treatment.
Arm Title
arthroscopic treatment
Arm Type
Other
Arm Description
Those participants with failed non-surgical treatment at 6 months will undergo arthroscopic treatment.
Intervention Type
Procedure
Intervention Name(s)
physiotherapy
Intervention Description
Six months physiotherapy aimed at hip stability.
Intervention Type
Procedure
Intervention Name(s)
arthroscopy
Intervention Description
Arthroscopic plication of hip joint capsule.
Primary Outcome Measure Information:
Title
Mean Change from Baseline in Hip Function on the International Hip Outcome Tool (iHOT-12) at 24 Months
Description
Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).
Time Frame
24 Months
Title
Mean Change from Baseline in Hip Function on the Copenhagen Hip and Groin Outcome Score (HAGOS) at 24 Months
Description
Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).
Time Frame
24 Months
Title
Mean Change from Baseline in Maximal Isometric Hip Muscle Force in Newton at 24 Months
Description
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.
Time Frame
24 Months
Title
Mean Change from Baseline in Hop Performance at 24 Months
Description
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.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in Hip Function on the EuroQoL-5 Dimensions (EQ-5D) at 24 Months
Description
Participant-reported health-related quality of life. Minimum score 0, maximum score 1 (higher score mean a higher health-related quality of life).
Time Frame
24 Months
Title
Mean Change from Baseline in Hip Function on the Hip Sport Activity Scale (HSAS) at 24 Months
Description
Participant-reported sport activity level. Minimum score 0, maximum score 8 (higher score mean a higher sport activity level).
Time Frame
24 Months
Title
Type and Number of Adverse Events at 24 Months
Description
Adverse events collected via phone interview.
Time Frame
24 Months
Title
Single Question "Satisfied with Treatment?" at 24 Months
Description
Participant-reported satisfaction with treatment (yes/no).
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Öhlin, MD, PhD
Phone
00460313430752
Email
axel.ohlin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mikael Sansone, MD, PhD
Phone
00460313430336
Email
mikael.sansone@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael Sansone, MD, PhD
Organizational Affiliation
Göteborg University
Official's Role
Study Director
Facility Information:
Facility Name
GHP Ortho Center Göteborg
City
Gothenburg
ZIP/Postal Code
41346
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mattias Ahldén, MD, PhD
Facility Name
University of Gothenburg
City
Gothenburg
ZIP/Postal Code
41676
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Öhlin, MD, PhD
Phone
0313430752
Ext
0046
Email
axel.ohlin@gmail.com
Facility Name
Capio Artro Clinic
City
Stockholm
ZIP/Postal Code
11428
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Stålman, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35361185
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability

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