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Femoracetabular ImpingementNCT02306525

Arthroscopic Treatment of Patients in Horsens and Aarhus With FemoroAcetabular Impingement: the HAFAI-cohort

An observational study of Femoracetabular Impingement, run by University of Aarhus at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: The aim of this prospective cohort is to evaluate patients before, 6 and 12 months after arthroscopic surgery for FAI and compare the results to people without hip problems. Methods/design: Sixty patients with FAI and 30 persons without hip problems will be included. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Femoracetabular Impingement
What is being tested?
Arthroscopic surgery of the hip joint
Type of treatment
Surgery or procedure
How many people
90 participants
Where
3 sitesDenmark
Study dates
Dec 2014to Mar 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Patients with Femoro Acetabular Impingement and Healthy volunteers

Who may be able to join

  • Planned hip arthroscopic treatment at Horsens Regional Hospital by Consultant Bent Lund
  • A diagnosis of CAM and/or pincer impingement
  • For patients with Cam, an alpha angle > 55 degrees on an anterior/posterior (AP) standing radiograph
  • For patients with Pincer a center edge angle > 25 degrees on an AP radiograph
  • No signs of retroversion in the lower 2/3 of the hip joint on an AP radiograph
  • No posterior wall sign on an AP radiograph
Show all 9Show fewer
  • Osteoarthritis grade 0-1 according to Tönnis' classification
  • Lateral Joint space width of > 3 mm
  • Age between 18 and 50 years

Who cannot join

  • Previous hip operations of the included hip
  • Persons with FAI secondary to other hip conditions such as Calvé Perthes and epiphysiolysis.
  • Alloplastic surgery at the hip, knee or ankle region (both legs)
  • Neurological diseases
  • Cancer
  • Inability to speak or understand Danish
Show all 10Show fewer
  • Pregnancy at the time of inclusion
  • Control persons (healthy volunteers):
  • Gender and age-matched persons
  • No known hip, knee or ankle region problems

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites
  • Aarhus University Hospital

    Aarhus, DK, 8000

  • Section of Sport, Aarhus University

    Aarhus, DK, 8000

  • Horsens Regional Hospital

    Horsens, DK, 8700

Other trials in Denmark

About this study

Official title: Outcome After Arthroscopic Treatment of Patients in Horsens and Aarhus With FemoroAcetabular Impingement: the HAFAI-cohort

Purpose: The aim of this prospective cohort is to evaluate patients before, 6 and 12 months after arthroscopic surgery for FAI and compare the results to people without hip problems.

Methods/design: Sixty patients with FAI and 30 persons without hip problems will be included. Pre- and postoperatively, patients will be evaluated by CT-scans. All participants will have their hip flexor and extensor muscle strength assessed and have performed kinetic and kinematic analyses of daily activities with 3D motion capture. Further, self-reported questionnaires on hip related pain, quality of life and sports activities will be collected. Finally, participants will have their daily physical activity monitored with tri-axial accelerometers for five consecutive days.

Perspectives: With this prospective cohort study the outcome of arthroscopic treatment of FAI within one year after surgery will be evaluated. If the patients fail to reach reference values one year after surgery, altered surgical procedures or rehabilitation programs to optimize treatment for the patients may be explored in future studies. Further, the investigators expect to perform long-term follow up to evaluate reoperations, conversions to total hip arthroplasty and development of osteoarthritis for the patients surgically treated for FAI.

Read the detailed description

Introduction Femoral acetabular impingement (FAI) is caused by an abnormality in the acetabular shape or orientation (Pincer-type) by a shape abnormality in the proximal femur (Cam-type) or by a mix of the two conditions. FAI causes repeated minor damage to the labrum and edge of the acetabulum. The damage to the joint is proposed to lead to early osteoarthritis (OA) of the hip, but whether FAI is a cause or result of OA is discussed. Surgery can reduce symptoms caused by Cam or Pincer impingement and may prevent future damage to the hip joint. However, different surgical techniques are used, and only few long-term studies of the surgery exist. The latest reviews conclude that 1) the effectiveness of the surgery is not clear, 2) it is not clear how surgery affects functional performance for the patients and 3) it is unknown how surgery for FAI affects the patients in a long-term perspective.

Material and methods

Patients:

Inclusion criteria

  • Planned hip arthroscopic treatment at Horsens Regional Hospital by Consultant Bent Lund
  • A diagnosis of CAM and/or pincer impingement
  • For patients with Cam, an alpha angle > 55 degrees on an anterior/posterior (AP) standing radiograph
  • For patients with Pincer a center edge angle > 25 degrees on an AP radiograph
  • No signs of retroversion in the lower 2/3 of the hip joint on an AP radiograph
  • No posterior wall sign on an AP radiograph
  • Osteoarthritis grade 0-1 according to Tönnis' classification
  • Lateral Joint space width of > 3 mm
  • Age between 18 and 50 years

Exclusion criteria

  • Previous hip operations of the included hip
  • Persons with FAI secondary to other hip conditions such as Calvé Perthes and epiphysiolysis.
  • Alloplastic surgery at the hip, knee or ankle region (both legs)
  • Neurological diseases
  • Cancer
  • Inability to speak or understand Danish
  • Pregnancy at the time of inclusion

Control persons (healthy volunteers) Thirty gender and age-matched persons with no known hip, knee or ankle region problems will be included as controls.

Primary outcome measures

  • Hip and pelvis kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand and drop jump
  • Hip extensor and flexor maximal muscle strength during isometric and isokinetic contractions
  • Hip extensor and flexor rate of force development during isometric contraction
  • Objectively measured daily physical activities during 5 days
  • Hip- related self-reported health measured with the Copenhagen Hip and Groin Outcome Score

Secondary outcome measures

  • Knee and trunk kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand and jump
  • Hip extensor and flexor rate of force development during isometric contraction
  • Self-selected walking speed
  • Presence of intra-articular pathology examined with FABER and impingement tests
  • Visual analog scale, pain
  • Patient expectations
  • Reasons for choosing surgery
  • Patient global treatment outcome
  • Patient-acceptable symptom state
  • EQ5D-Visual analog scale
  • Failure
  • Re-operations and injections during the first year after surgery
  • Self-reported present sports activities
  • Time spend at preferred sports activity present
  • Time spend at sports activities during childhood
  • Sports activities during childhood
  • Return to sports activities
  • Education
  • Employment
  • Smoking habits
  • Alcohol intake
  • Intake of analgesia
  • Comorbidities

Other Pre-specified Outcome Measures:

  • Alpha angle
  • Wiberg's center-edge (CE) angle
  • Tönnis' acetabular index (AI)
  • Retroversion of acetabulum
  • The position of the femoral head in relation to the neck
  • Osteoarthritis grade according to Tönnis' classification
  • Lateral hip joint space width
  • Information about the surgical procedure immediately
  • Deviation from rehabilitation program
  • Duration of pain
  • Body Mass Index
  • Body fat percentage
  • Age

Procedure

Patients scheduled for hip arthroscopic treatment at Horsens Regional Hospital will receive written and verbal information about the study and after informed consent included consecutively. After agreeing to participate, the patients will have a pre-operative CT-scan of the included hip. At Aarhus University, patients will have a clinical examination session including measurement of height, weight and fat percentage. They will have their hip extensor and flexor muscle strength assessed in an isokinetic dynamometer and perform walking, stair climbing, stepping, sit to stand and a drop jump with 3D-motion capture. Patients will complete the HAGOS-questionnaire together with the other pre specified self-reported measures described.

After all tests are completed, the patients will be instructed in wearing a 3-axial accelerometer for five days, attached to the thigh of the non-affected leg to monitor daily physical activity.

At a three, six and nine month follow-up patients will complete HAGOS, pain scores and self-reported measures of return to sport, work, re-operations and injections after surgery and EQ5D-Visual analog scale.

At a one year follow up, preoperative measures will be repeated. Further, at six month and one year follow up the patients will report fulfillment of expectations, patient global treatment outcome and patient willingness to repeat surgery.

All controls will meet at Aarhus University for a single assessment of the same measures as the patients except from CT-scans and outcome measures related to the surgery.

Statistics

Patients and controls will be compared with multiple regression analysis adjusted for age, gender and body weight if the assumptions for the model is met. If not, they will be compared using un-paired non-parametric statistics.

The longitudinal measures of the patients pre, three, six, nine month and one year after surgery will be evaluated in a paired set-up.

Further analyses

Based upon the preoperative CT-scan, the patients will be split into subgroups: FAI will be classified as Cam (alpha angle > 55˚), Pincer (center edge angle > 25˚ from CT and AP radiograph and/or crossing sign and ishial spine sign) and Mixed when there is a combination of Cam and Pincer. We will investigate how these subgroups affects outcome measures. Further, we will investigate how demographics, preoperative and postoperative muscle strength and pain affects the results of the surgery and rehabilitation procedure.

Sample size

The primary end point for the study is one year after surgery. For the muscle strength assessment, sample size is based upon pre- and post-operative values from Casartelli et al. (2) with a level of significance of 0.05 and a power of 90 %, the patient group should consist at least 53 persons. Taking possible drop-outs in account our goal is to include 60 patients. We will include 30 controls persons for comparisons.

Ethics

The Danish Biomedical Research Ethics Committee, Central Denmark Region (1-10-72-239-14) and the Danish Data Protection Agency have approved the project (1-16-02-499-14).

Economy and dissemination

Financial support will be applied for at internally at our institution and externally at various foundations. Both positive, negative and inconclusive results will be published in international journals and presented at conferences.

References

  1. Mannion AF, Impellizzeri FM, Naal FD, Leunig M: Fulfilment of patient-rated expectations predicts the outcome of surgery for femoroacetabular impingement. Osteoarthritis and Cartilage 2013, 21:44-50.
  2. Casartelli NC, Maffiuletti NA, Item-Glatthorn JF, Impellizzeri FM, Leunig M: Hip muscle strength recovery after hip arthroscopy in a series of patients with symptomatic femoroacetabular impingement. Hip international : the journal of clinical and experimental research on hip pathology and therapy 2014:0.
  3. Paulsen A, Roos EM, Pedersen AB, Overgaard S. Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively. Acta orthopaedica. 2014;85(1):39-48.
Being tested
Arthroscopic surgery of the hip joint
Medical subject headings
Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arthroscopic surgery of the hip jointProcedure or surgery

    Also called Hip Arthroscopy, Arthroscopic surgery of Femoro-Acetabular Impingement

    Arthroscopic treatment of Femoroacetabular Impingement

Study groups in NCT02306525
Study groupRoleWhat they receive
Ptt. with Femoracetabular ImpingementEnrollment anticipated: 60 Arthroscopic surgery of the hip joint
Receives: Procedure: Arthroscopic surgery of the hip joint
Healthy volunteersEnrollment anticipated: 30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hip and pelvis kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand and drop jump

    Hip and pelvis kinetics and kinematics are measured with a 3D motion capture system with a force platform using a standardized protocol

    Measured: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery

  2. Hip extensor and flexor maximal muscle strength during isometric and isokinetic contractions

    Hip extensor and flexor maximal strength is measured with an isokinetic dynamometer using a standardized protocol

    Measured: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery

  3. Objectively measured daily physical activities during five days

    Physical activity is measured with a tri-axial accelerometer during a period of 5 days on the following categories: rest, standing, walking, sit to stand, cycling and high impact activity.

    Measured: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery

  4. Hip-related self-reported health

    Hip related health is measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) validated on patients with hip and groin pain

    Measured: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery

Secondary outcomes (22)
  1. Knee and trunk kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand drop jump

    Knee and trunk kinetics and kinematics are measured with a 3D motion capture system with a force platform using a standardized protocol

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery

  2. Hip extensor and flexor rate of force development during isometric contraction

    Hip extensor and flexor rate of force development is measured with an isokinetic dynamometer using a standardized protocol

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery

  3. Self-selected walking speed

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery

  4. Presence of intra-articular pathology examined with FABER and impingement tests

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery

  5. Visual analog scale, pain

    Pain is measured during rest and activity with a visual analog scale. Further patients will report their pain at a visual analog scale during all physical performance tests

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery

  6. Patient expectations

    The question, "what changes in the following items do you expect to experience as a result of the operation? (not your hopes and wishes, but realistic expectations!)" will be asked in relation to each of six items: hip pain, walking capacity, independence in everyday activities, ability to do sport, engaging in social contacts, mental well-being. The response options will be: much better, better, somewhat better, unchanged, worse, "I don't know". After surgery, the same response options will be given together with the question: "what changes in the following items have occurred as a result of the operation?" (Adapted from Mannion et al. (1))

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery

  7. Reasons for choosing surgery

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)

  8. Patient global treatment outcome

    The question: "How much did the operation help your hip problem?" will be asked together with the options: helped a lot, helped, helped only little, didn't help, made things worse. Adapted from Mannion et al. (1)

    Measured: Six month and one year after surgery

  9. Patient-acceptable symptom state

    The question "How would you describe the result of your operation?" will be asked. There will be 5 response options: "Excellent", "Very good", "Good", "Fair", and "Poor". Adapted from Paulsen et al. (3)

    Measured: Six month and one year after surgery

  10. EQ5D-Visual analog scale

    Overall health will be evaluated with the EQ5D- Visual analog scale

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery

  11. Failure

    The surgical treatment and rehabilitation will be considered a failure if the patient have received a total hip arthroplasty

    Measured: One year after surgery

  12. Re-operations and injections during the first year after surgery

    Measured: 3 month, 6 month, 9 month and one year after surgery

  13. Self-reported present sports activities

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery

  14. Time spend at preferred sports activity

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery

  15. Sports activities during childhood (age < 18)

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)

  16. Time spend at sports activities during childhood

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)

  17. Education

    Measured: Preoperatively (Approx. i the time frame 0-10 weeks before surgery)

  18. Employment

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)

  19. Smoking habits

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), one year after surgery

  20. Alcohol intake

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), one year after surgery

  21. Intake of analgesia

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery

  22. Comorbidities

    Patients will report comorbidities as hypertension, diabetes ect.

    Measured: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02306525
Sponsor's protocol ID
1-10-72-239-14
Other IDs
1-16-02-499-14
Status last verified
Sep 2019
First submitted
21 Nov 2014
Last updated
4 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Kierkegaard S, Lund B, Dalgas U, Sorensen H, Soballe K, Mechlenburg I. The Horsens-Aarhus Femoro Acetabular Impingement (HAFAI) cohort: outcome of arthroscopic treatment for femoroacetabular impingement. Protocol for a prospective cohort study. BMJ Open. 2015 Sep 7;5(9):e008952. doi: 10.1136/bmjopen-2015-008952.

    PubMed 26346877

Questions about this trial

What is this clinical trial studying?

An observational study of Femoracetabular Impingement, run by University of Aarhus at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hip and pelvis kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand and drop jump (time frame: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02306525, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.

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