Arthroscopic surgery of the hip joint
ProcedureArthroscopic treatment of Femoroacetabular Impingement
Other names: Hip Arthroscopy, Arthroscopic surgery of Femoro-Acetabular Impingement
NCT Number: NCT02306525
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.
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Notify Me18 year–50 year
All sexes
Observational
Aarhus University Hospital, Aarhus, DK, Denmark
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
Exclusion criteria
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
Secondary outcome measures
Other Pre-specified Outcome Measures:
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(patients):
Exclusion criteria
(patients):
Control persons (healthy volunteers):
Arthroscopic treatment of Femoroacetabular Impingement
Other names: Hip Arthroscopy, Arthroscopic surgery of Femoro-Acetabular Impingement
Time frame: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery
Hip and pelvis kinetics and kinematics are measured with a 3D motion capture system with a force platform using a standardized protocol
Time frame: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery
Hip extensor and flexor maximal strength is measured with an isokinetic dynamometer using a standardized protocol
Time frame: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery
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.
Time frame: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery
Hip related health is measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) validated on patients with hip and groin pain
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Knee and trunk kinetics and kinematics are measured with a 3D motion capture system with a force platform using a standardized protocol
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Hip extensor and flexor rate of force development is measured with an isokinetic dynamometer using a standardized protocol
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
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
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery
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))
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)
Time frame: Six month and one year after surgery
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)
Time frame: Six month and one year after surgery
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)
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery
Overall health will be evaluated with the EQ5D- Visual analog scale
Time frame: One year after surgery
The surgical treatment and rehabilitation will be considered a failure if the patient have received a total hip arthroplasty
Time frame: 3 month, 6 month, 9 month and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)
Time frame: Preoperatively (Approx. i the time frame 0-10 weeks before surgery)
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)
Patients will report comorbidities as hypertension, diabetes ect.
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Time frame: Prior to surgery (Preoperatively (Approx. in the time frame 0-10 weeks before surgery)and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Measured at low dosis CT-scans
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Measured at low dosis CT-scans
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Time frame: Immediately after completing surgical procedure
Described by the surgeon after leaving the operation theater
Time frame: During the rehabilitation period that lasts around 1 year
Deviation from rehabilitation program will be recorded by physiotherapists
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery
Time frame: Preoperatively (Approx. in the time frame 0-10 weeks before surgery)
Time frame: 3, 6 and 9 months after surgery
Hip related health is measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) validated on patients with hip and groin pain
University of Aarhus
Other
Outcome After Arthroscopic Treatment of Patients in Horsens and Aarhus With FemoroAcetabular Impingement: the HAFAI-cohort
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