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

NCT02306525 | Completed DMC

• 2 other identifiers: 1-10-72-239-141-16-02-499-14
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Femoracetabular Impingement

Outcome Measures

Primary Outcomes (4)

• 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

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

• 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

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

• 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.

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

• 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

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

Secondary Outcomes (22)

• Knee and trunk kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand drop jump

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

• Hip extensor and flexor rate of force development during isometric contraction

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

• Self-selected walking speed

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

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

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

• Visual analog scale, pain

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

Other Outcomes (14)

• Alpha angle

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

• Wiberg's center-edge (CE) angle

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

• Tönnis' acetabular index (AI)

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

Study Arms (2)

Ptt. with Femoracetabular Impingement

Enrollment anticipated: 60 Arthroscopic surgery of the hip joint

Procedure: Arthroscopic surgery of the hip joint

Healthy volunteers

Enrollment anticipated: 30

Interventions

Arthroscopic surgery of the hip joint PROCEDURE

Arthroscopic treatment of Femoroacetabular Impingement

Also known as: Hip Arthroscopy, Arthroscopic surgery of Femoro-Acetabular Impingement

Ptt. with Femoracetabular Impingement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Femoro Acetabular Impingement and Healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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
• Control persons (healthy volunteers):
• Gender and age-matched persons
• No known hip, knee or ankle region problems

Sponsors & Collaborators

• University of Aarhus: lead
• Horsens Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (3)

Aarhus University Hospital

Aarhus, DK, 8000, Denmark

Location

Section of Sport, Aarhus University

Aarhus, DK, 8000, Denmark

Location

Horsens Regional Hospital

Horsens, DK, 8700, Denmark

Location

Related Publications (1)

• 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.

  PMID: 26346877 DERIVED

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Inger Mechlenburg, PhD

  Orthopedic Research, Aarhus University and University Hospital, Denmark

  STUDY DIRECTOR

• Kjeld Søballe, Professor,MD

  Orthopedic Research, Aarhus University and University Hospital, Denmark

  STUDY CHAIR

• Ulrik Dalgas, PhD

  Section of Sport, Aarhus University, Denmark

  STUDY CHAIR

• Bent Lund, MD

  Horsens Regional Hospital, Denmark

  STUDY CHAIR

• Henrik Sørensen, PhD

  Section of Sport, Aarhus University, Denmark

  STUDY CHAIR

• Lone Rømer, MD

  Aarhus University Hospital, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 3, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

DK (3)