Targeted Exercise and Changes in Femoroacetabular Impingement in Symptomatic Patients With Acetabular Retroversion

Study Overview
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Brief Summary
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The objective of this study is to investigate the effectiveness of an 8-week home-based targeted training intervention aiming at reducing FAI related pain, anterior pelvic tilt and improve hip joint function in a cohort of 40 patients (18 to 40 years), with acetabular retroversion and anterior pelvic tilt not eligible for surgery (Ganz osteotomy) from the hospital outpatient clinic.

Detailed Description
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Acetabular retroversion is a variation of hip dysplasia, reported in the normal population from 6 % to 48 %, enhancing the risk of femoroacetabular impingement (FAI) in especially hip flexion and is associated with pain, reduced level of function, decreased health-related quality of life and early development of osteoarthritis (OA) of the hip. A higher degree of anterior pelvic tilt increases the risk of FAI and especially in standing, sitting and squatting positions it has been found to correlate with FAI. Periacetabular osteotomy (Ganz osteotomy) is performed as a surgical joint preserving reorientation of the entire acetabulum with a subsequently long period of rehabilitation. There is currently no existing alternative (i.e. non-surgical) treatment to surgery for this patient group. Therefore, the objective of this study is to test a targeted training intervention aiming at reducing anterior pelvic tilt and improve hip joint function in patients with symptomatic acetabular retroversion. A prospective cohort study of 40 patients will undergo an 8-week targeted exercise intervention executed as progressive home-based training with supervised booster-sessions. Patients (18 to 40 years) with acetabular retroversion and anterior pelvic tilt not eligible for surgery (Ganz osteotomy) will be recruited from the outpatient clinic. Time points for testing are at 1) minus 8-weeks (beginning of control-period) 2) baseline (beginning of training period) 3) plus 8-weeks (end of training period) and 4) plus 26 weeks from baseline (follow up). The primary outcome measure is self-perceived level of hip related pain (HAGOS questionnaire subscale). Secondary outcome measures are self-perceived level of function and quality of life (remaining HAGOS-subscales), EQ-5D-3Levels questionnaire and radiographic degree of pelvic tilt in standing posture (EOS-scanning). Explorative outcome measures include additional radiographic measurements, patient-reported outcome measurements (PROM´s), functional testing and physical performance. The primary endpoint for assessing the outcome of the intervention will be 8 weeks after start of intervention. At 26-week follow up, only the PROM´s will be applied. All participants must fill in a mandatory exercise related dairy concerning adherence, level of pain and potential adverse events. The study is approved by the Regional Committees on Health Research Ethics for Southern Denmark, Project ID: S-20160072 Forty participants in total will be enrolled from the hip outpatient clinic at Odense University Hospital, Denmark. Paired means sample size calculation = 36 (10 % pre-posttest difference on HAGOS pain-subscale, SD=20.6, alpha = 0.05, power = 80 %), plus 10 % dropout = 4. A list generated of 20 randomly found numbers from 1-40 will be used to select participants to be investigated in the motion laboratory. The number on the list corresponds to the order the participants are recruited into the study. In the motion laboratory, the explorative outcomes Functional testing (3D motion capture) and Physical performance (isometric muscle strength, joint range-of-motion, and single-leg hop for distance) will be tested. To our knowledge, this is the first study investigating a targeted training intervention aiming at reducing FAI related pain, anterior pelvic tilt and improve hip joint function in patients with acetabular retroversion. Consequently, the study will provide knowledge that may help to develop non-surgical treatment strategies for this group of patients.

Official Title
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A Prospective Cohort Study on Targeted Exercise and Changes in Femoroacetabular Impingement in Symptomatic Patients With Acetabular Retroversion (TILT-FAI)

Conditions
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Acetabular Dysplasia

Intervention / Treatment
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* Other: Targeted training intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed from a standard standing anterior-posterior pelvic radiograph with acetabular retroversion due to cross-over-sign and posterior-wall-sign Not eligible for Ganz osteotomy Ability to take part in the intervention Exclusion Criteria: Having a Pelvic Tilt Ratio greater than 0.5, (the height of the obturator foramen divided by the height of the lesser pelvis) indicating posterior pelvic tilt, assessed from a standard standing AP-pelvic radiograph Radiographic sign of hip osteoarthritis (< 2mm. joint space), Previous lumbar, pelvic or hip related operations Conditions not allowing exercise therapy Body mass index (BMI) above 35 Not understanding spoken and/or written Danish language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted training intervention<br>An 8-week progressive homebased training intervention with supervised booster-sessions | Other: Targeted training intervention<br>* An 8-week progressive homebased training intervention with supervised booster-sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAGOS questionnaire (pain subscale) | Change in The Copenhagen Hip and Groin Outcome Score (HAGOS) questionnaire pain subscale. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4, where 0 indicates no problem. The scores from each subscale are calculated as the sum of the items included. Raw scores are then transformed to a 0-100 scale, with zero representing extreme hip and/or groin problems and 100 representing no hip and/or groin problems. | Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAGOS questionnaire (the remaining five subscales) | Change in the remaining five HAGOS-subscales (Symptoms, Physical function in daily living, Physical function in Sport and Recreation, Participation in Physical Activities and hip and/or groin-related Quality of Life). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4, where 0 indicates no problem. The scores from each subscale are calculated as the sum of the items included. Raw scores are then transformed to a 0-100 scale, with zero representing extreme hip and/or groin problems and 100 representing no hip and/or groin problems. | Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline) | 
| EQ-5D-3Levels questionnaire | Change in the European Quality of Life - 5 Dimensions (EQ-5D-3Levels) questionnaire, Danish version. For each dimension (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression) standardized answer options are divided in levels of perceived problems (3 Likert boxes): Level 1: indicating no problem, Level 2: indicating some problems, Level 3: indicating extreme problems. A unique health state is defined by combining the selected level from each of the 5 dimensions. In addition, the overall health state the actual day is marked on a numeric scale on which the best state is marked 100 and the worst state is marked 0. | Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline). | 
| Radiographic measurement of pelvic tilt (SCJ - Symphysis distance) | Change in the degree of pelvic tilt measured in the frontal plane as the distance (in mm) from the sacro-coccygeal joint (SCJ) to the upper border of the pubic symphysis (standing EOS scanning) | Minus 8-weeks (control), baseline, 8-weeks (post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoroacetabular Impingement, Anterior Pelvic Tilt