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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03669471
Other study ID # FAIS2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 13, 2018
Est. completion date December 15, 2019

Study information

Verified date December 2019
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) decreased hip muscle strength for adduction, extension, flexion, and external rotation including impaired functional performance have been observed. However, no studies are lacking on more demanding muscular and functional parameters such as hip muscle rate of force development and reactive strength index. Information on such muscular properties following hip arthroscopy for FAIS may help guide future planning of post-operative rehabilitation strategies.

This is a cross-sectional study with an embedded prospective non-randomized study. The aim of the cross-sectional study is to investigate hip muscle function and functional performance in patients who have undergone hip arthroscopy for FAIS during the preceding 6-30 months.

The aim of the prospective non-randomized study is to investigate the effect of a 12-week structured and supervised physiotherapy-led intervention aiming at improving hip muscular function on self-reported hip and groin function including hip muscle function and functional performance.

Forty-five subjects from the Capital Region with an age of 18-40, who have undergone a hip arthroscopy for FAIS during the last 6-30 months, will be included in the cross-sectional study. Additionally, all included subjects will be offered to take part in the prospective non-randomized study consisting of 12 weeks of supervised and structured physiotherapy-led treatment.

The below measures will be obtained at baseline, and at 12-weeks follow-up if subjects are included in the prospective study. All testing, and supervised physiotherapy-led treatment, will be performed at Hvidovre Hospital:

1. Hip muscle function

2. Single leg jump performance

3. Self-reported hip and groin function

4. Evaluation of return to sport

5. Evaluation of satisfaction regarding usual-care post-operative rehabilitation


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 15, 2019
Est. primary completion date September 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Male/female at the age of 18-40 years at the time of surgery

- Undergone hip arthroscopy for FAIS during the previous 6-30 months (surgical procedure: cam resection and labral surgery)

- Pre-operative cam morphology specified as an alpha angle =55°

Exclusion Criteria:

- Pre-surgery joint space width <3 mm

- Any of the following surgical procedures at any time: extra articular surgery of the hip joint (except capsular closure), microfracture, periacetabular osteotomy, and surgery of the ligamentum teres; previous hip arthroscopy in the same hip joint; previous hip pathology such as Perthes' disease, slipped upper femoral epiphysis, hip dysplasia (Lateral Center Edge Angle <25°), and/or avascular necrosis; Any rheumatoid disease in the hip joint such as synovial chondromatosis.

Study Design


Intervention

Other:
Testing of performance
The cross-sectional evaluation will involve assessment of: Hip muscle function Single leg jump performance Self-reported hip and groin function Evaluation of return to sport Evaluation of satisfaction regarding usual-care post-operative rehabilitation The exercise-based treatment will involve criteria-based physiotherapy aiming at improving muscle function around the hip and trunk.

Locations

Country Name City State
Denmark Testing and exercise-based intervention will be conducted at Hvidovre Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak force Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion Baseline (week 0)
Primary Rate of force development 0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion Baseline (week 0)
Primary Self-reported hip and groin function (subjects included in prospective study) Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems) Baseline (week 0) and follow-up (week 12)
Secondary Single leg jump performance Reactive strength index obtained during a single leg drop jump test Baseline (week 0)
Secondary Self-reported hip and groin function Obtained using the Copenhagen Hip and Groin Outcome Score (HAGOS); Scale from 0 (extreme hip and groin problems) to 100 (no hip and groin problems) Baseline (week 0)
Secondary Return to sport Obtained using a return to sport questionnaire; Scale: Preinjury sport at preinjury level vs. not preinjury sport at preinjury level. Baseline (week 0)
Secondary Satisfaction regarding usual-care post-operative rehabilitation Obtained using a questionnaire; Scale: Satisfied with regular post-operative rehabilitation vs. not satisfied with post-operative rehabilitation. Baseline (week 0)
Secondary Change in Peak force (subjects included in prospective study) Peak isometric hip torque (Nm/kg) of abduction, adduction, extension, and flexion Baseline (week 0) and follow-up (week 12)
Secondary Change in rate of force development (subjects included in prospective study) 0-100 ms and 0-200 ms rate of torque development (Nm/s/kg) of abduction, adduction, extension, and flexion Baseline (week 0) and follow-up (week 12)
Secondary Change in Single leg jump performance (subjects included in prospective study) Reactive strength index obtained during a single leg drop jump test Baseline (week 0) and follow-up (week 12)
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