Clinical trial NCT04934462: 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
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Abnormalities
Hip Injuries
Keywords: arthroscopy
physiotherapy
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: The Swedish Society of Medicine
name: Stanford University
First posted: 2021-06-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Change from Baseline in Hip Function on the International Hip Outcome Tool (iHOT-12) at 24 Months
timeFrame: 24 Months
measure: Mean Change from Baseline in Hip Function on the Copenhagen Hip and Groin Outcome Score (HAGOS) at 24 Months
timeFrame: 24 Months
measure: Mean Change from Baseline in Maximal Isometric Hip Muscle Force in Newton at 24 Months
timeFrame: 24 Months
measure: Mean Change from Baseline in Hop Performance at 24 Months
timeFrame: 24 Months
Secondary outcomes:
measure: Mean Change from Baseline in Hip Function on the EuroQoL-5 Dimensions (EQ-5D) at 24 Months
timeFrame: 24 Months
measure: Mean Change from Baseline in Hip Function on the Hip Sport Activity Scale (HSAS) at 24 Months
timeFrame: 24 Months
measure: Type and Number of Adverse Events at 24 Months
timeFrame: 24 Months
measure: Single Question "Satisfied with Treatment?" at 24 Months
timeFrame: 24 Months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: GHP Ortho Center Göteborg
city: Gothenburg
country: Sweden
facility: University of Gothenburg
city: Stockholm
country: Sweden
facility: Capio Artro Clinic
Study officials:
affiliation: Göteborg University
name: Mikael Sansone, MD, PhD
role: STUDY_DIRECTOR
References:
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.