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Completed

NCT Number: NCT03578562

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

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.

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Key information

Conditions

Acetabular Dysplasia Femoracetabular Impingement Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern Denmark - Odense University Hospital

Odense C, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted training intervention

Other

An 8-week progressive homebased training intervention with supervised booster-sessions

Primary outcomes

  1. HAGOS questionnaire (pain subscale)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline)

    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.

Secondary outcomes

  1. HAGOS questionnaire (the remaining five subscales)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline)

    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.

  2. EQ-5D-3Levels questionnaire

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline).

    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.

  3. Radiographic measurement of pelvic tilt (SCJ - Symphysis distance)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    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)

Other outcomes

  1. Global Perceived Effect anchor-question

    Time frame: 8-weeks (post-intervention) and 26 weeks (follow up from baseline)

    Changed from baseline on a 7-point Likert scale: ´much better, better, little better, unchanged, little worse, worse, much worse'.

  2. Oxford 12-item Hip Score (OHS) questionnaire, Danish version

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline)

    Change in Oxford Hip Score (OHS) questionnaire. Standardized answer options are given (5 Likert boxes) and each question gets a score from 1 to 5, where 1 indicates no problem. The score is calculated as the sum of the 12 questions. The score can therefore be 12-60. The higher the score, the lower the function level.

  3. UCLA activity scale

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention) and 26 weeks (follow up from baseline).

    Change in the University of California Los Angeles activity-level rating (UCLA activity scale), Danish version. On a 10-point scale, the option is marked that matches the level of intensity and frequency of physical activity best, where 1 ="Wholly inactive: depend on others, cannot leave residence, and 10 =" Regularly participates in impact sports".

  4. Radiographic measurement of pelvic tilt (pelvic tilt ratio)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in pelvic tilt ratio measured in the frontal plane (standing EOS scanning) and calculated as the centrally height (in mm) of the obturator foramens divided by the centrally height (in mm) of the lesser pelvis (the distance from the two lower margins of the sacroiliac joint to the upper border of the two obturator foramens).

  5. Radiographic measurement of pelvic tilt (sagittal plane)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in pelvic tilt (in degrees) measured in the sagittal plane (standing EOS scanning) as the angle between a horizontal line and a line connecting the upper border of the symphysis with the sacral promontory.

  6. Radiographic measurements of pelvic parameters (Pelvic Incidence)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in Pelvic Incidence (in degrees) measured as the angle between the line joining the hip axis and the center of the S1 end-plate and the line orthogonal to the S1 end-plate (standing EOS scanning)

  7. Radiographic measurements of pelvic parameters (Pelvic Tilt)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in Pelvic Tilt (in degrees) measured as the angle between the line joining the hip axis and the center of the S1 end-plate and a reference vertical line (standing EOS scanning)

  8. Radiographic measurements of pelvic parameters (Sacral Slope)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in Sacral Slope (in degrees) measured as the angle between the line along the S1 end-plate and a reference horizontal line (standing EOS scanning)

  9. Radiographic parameters of acetabular retroversion (Cross-Over Sign)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in Cross-Over Sign (yes/no) (standing EOS scanning)

  10. Radiographic parameters of acetabular retroversion (Cross-Over Ratio)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in Acetabular Cross-Over Ratio (percent) (standing EOS scanning)

  11. Radiographic parameters of acetabular retroversion (Posterior Wall Sign)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in Posterior Wall Sign (yes/no) (standing EOS scanning)

  12. Radiographic parameters of acetabular retroversion (Posterior Wall Ratio)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in Posterior Wall Ratio (percent) (standing EOS scanning)

  13. Radiographic parameters of acetabular retroversion (Ischial Spine Sign)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in Ischial Spine Sign (yes/no) (standing EOS scanning)

  14. Physical performance (hip muscle strength)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in maximal isometric hip extension, flexion and abduction muscle strength (in Nm using dynamometry)

  15. Physical performance (abdominal muscle strength)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in maximal isometric abdominal muscle strength (in Nm using dynamometry)

  16. Physical performance (hip ROM)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in hip extension range-of-motion (in degrees using goniometry)

  17. Physical performance (lumbar spine ROM)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in lumbar spine flexion range-of-motion (in cm. using Schobers test)

  18. Physical performance (Single-leg hop for distance)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention).

    Change in the horizontal single-leg hop distance (in cm) from the toe in the starting position to the heel in the landing position.

  19. Functional test (3D Gait analysis - kinetics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in peak- and mean hip joint moments (in Nm) using 3D Vicon motion capture analysis

  20. Functional test (3D Gait analysis - kinematics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in hip joint range-of-motion (in degrees) using 3D Vicon motion capture analysis

  21. Functional test (3D deep squat analysis - kinetics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in peak- and mean hip joint moments (in Nm) using 3D Vicon motion capture analysis

  22. Functional test (3D deep squat analysis - kinematics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in hip joint range-of-motion (in degrees) using 3D Vicon motion capture analysis

  23. Functional test (3D deep squat analysis, with heel support - kinetics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in peak- and mean hip joint moments (in Nm) using 3D Vicon motion capture analysis

  24. Functional test (3D deep squat analysis, with heel support - kinematics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in hip joint range-of-motion (in degrees) using 3D Vicon motion capture analysis

  25. Functional test (3D counter movement jump analysis, unilateral - kinetics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in peak- and mean hip joint moments (in Nm) using 3D Vicon motion capture analysis

  26. Functional test (3D counter movement jump analysis, unilateral - kinematics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in hip joint range-of-motion (in degrees) using 3D Vicon motion capture analysis

  27. Functional test (3D counter movement jump analysis, bilateral - kinetics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in peak- and mean hip joint moments (in Nm) using 3D Vicon motion capture analysis

  28. Functional test (3D counter movement jump analysis, bilateral - kinematics)

    Time frame: Minus 8-weeks (control), baseline, 8-weeks (post-intervention)

    Change in hip joint range-of-motion (in degrees) using 3D Vicon motion capture analysis

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Odense University Hospital
  • The Danish Rheumatism Association
  • University College Absalon. Region of Zealand, Denmark
  • Vanfoerefonden, Denmark

Registry information

Official study title

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

Acronym: TILT-FAI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2018
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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