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Arthroscopic Surgical Procedures vs Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears. (HIPARTI)

This study is currently recruiting participants.
Verified February 2017 by May Arna Risberg, Oslo University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02692807
First Posted: February 26, 2016
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
La Trobe University
University of Aarhus
Lund University
University of Oxford
University of Ottawa
Information provided by (Responsible Party):
May Arna Risberg, Oslo University Hospital
  Purpose

The primary aim of this study is to determine the efficacy of hip arthroscopic surgery compared to a sham surgery (diagnostic arthroscopy only) for patients with symptomatic and radiological findings related to impingement (FAI) and/or labral tears using a randomized controlled design (HIPARTI Study: Primary aim and the main paper: primary end point: iHOT 1 year follow-up)).

Our main hypothesis is that surgical procedures of the hip will demonstrate greater efficacy than sham surgery (diagnostic hip arthroscopy only) for hip related quality of life (iHOT-33) after 1 year and at further (HIPARTI Study).

The secondary aim of this study is to establish modifiable risk factors associated with pain, function, work participation and quality of life over 1 year in people aged 18-50 years with hip impingement and/or labral tears diagnosed at hip arthroscopy. (HARP Study: A separate paper will be published with this main aim for the HARP Study) Long-term follow-ups for HIPARTI Study as well as HARP Study will be performed at 2, 5 and 10 years (secondary aims and separate papers).


Condition Intervention
Surgery Procedure: Arthroscopic surgical procedures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The RCT part of the HIPARTI Study has 2 arms, but there is also a prospective longitudinal study of those who are either not willing to participate in the RCT, or where the study takes part in collaborating countries were there is ONLY the prospective longitudial ongoing (Australia). This part of the study is the HARP study. The HIPARTI consists on one RCT trial eith two parallel arms, and one prospective cohort, the HARP study.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
This is only for the RCT Study - the double-blinded study. The HARP study consists of only a prospective longitudial study With same outcome measure and follow-ups; hence, given 3 arms. The below "Allocation" and "Number of Subjects" is ONLY for the RCT part of the study
Primary Purpose: Treatment
Official Title: Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears. A Multicentre, International, Double-blinded Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by May Arna Risberg, Oslo University Hospital:

Primary Outcome Measures:
  • International Hip Outcome Tool (IHOT-33) [ Time Frame: Baseline, 6,12 an 24 months follow-ups - 1 year follow-up is main outcome ]
    Patient-reported outcome measure (PRO)


Secondary Outcome Measures:
  • Expectations of surgery [ Time Frame: Baseline ]
    Questionnaire

  • HOOS - Hip Dysfunction and Osteoarthritis Outcome Score [ Time Frame: Baseline, 6,12 an 24 months follow-ups - only in some study sites ]
    Patient-reported outcome measure (PRO) 5 subscales

  • ASES Arthritis Self-Efficacy Scale [ Time Frame: Baseline, 6,12 an 24 months follow-ups ]
    Self-Efficacy Scale questionnaire

  • Tampa scale of Kinesiophobia [ Time Frame: Baseline, 6,12 an 24 months follow-ups ]
    Fear of movement questionnaire

  • Hip Sports Activity Scale (HSAS) [ Time Frame: Baseline, 6,12 an 24 months follow-ups ]
    Activity Level (type)

  • Work place Activity Limitation Survey (WALS) [ Time Frame: Baseline, 6,12 an 24 months follow-ups ]
    Questionnaire (only for some of the study sites)- only in some study sites

  • Patient Spesific Functional Scale [ Time Frame: Baseline, 6,12 an 24 months follow-up ]
    Patient report on 3 specific activities and their limitations - only in some study sites

  • Measures of hip physical impairment: [ Time Frame: Baseline, 6,12 an 24 months follow-ups ]
    Range of motion

  • Hip muscle strength [ Time Frame: Baseline, 6,12 an 24 months follow-ups ]
    Dynamometer

  • Single leg squat performance [ Time Frame: Baseline, 6,12 an 24 months follow-ups ]
    Performance tests - only in some study sites

  • Total Hip Replacement. [ Time Frame: 1, 2, 5 and 10 years follow-up ]
    Data from the Norwegian National Joint Registry on total hip joint arthroplasty (or similar registries from the other countries)


Estimated Enrollment: 140
Study Start Date: February 2016
Estimated Study Completion Date: December 2035
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hip arthroscopy surgical procedures (HIPARTI Study)
Surgery is performed under general anaesthesia. Traction and joint access is controlled by fluoroscopy. A diagnostic round in the central and peripheral compartment is performed. Labrum, cartilage, and other possible conditions are looked for and findings are documented. Any labral, chondral and bony pathology (cam or pincer) is treated. Labrum may be debrided, sutured, detached and refixed if needed to treat a pincer lesion. Labrum is secured with suture anchors. Pincer and cam resection is performed using an arthroscopic burr. Cartilage lesions maybe left untreated or treated with debridement or microfracture.
Procedure: Arthroscopic surgical procedures
See arm/group description of Arthroscopic surgery and sham surgery (HIPARTI). HARP: only arthroscopic surgery
Other Name: Sham Surgery
Placebo Comparator: Sham surgery (HIPARTI Study)
The same arthroscopic procedures as stated above are preformed, but no surgical interventions related to Cam, Pincer, or labral tear are performed, only diagnostic round in the central and peripheral compartment is performed. Labrum, cartilage, and other possible conditions are looked for and findings are documented.
Procedure: Arthroscopic surgical procedures
See arm/group description of Arthroscopic surgery and sham surgery (HIPARTI). HARP: only arthroscopic surgery
Other Name: Sham Surgery
Active Comparator: Prospective Cohort (HARP Study)
Those that are not willing to be included in the RCT (HIPARTI Study), will be asked if they are willing to be included in the prospective cohort, or ongoing in countries were ONLY the surgery is performed (Australia). They will sign an informed concent and will undergo surgical interventions as part of usual care. Outcomes collected and follow-ups will be the same as for the RCT (HIPARTI).
Procedure: Arthroscopic surgical procedures
See arm/group description of Arthroscopic surgery and sham surgery (HIPARTI). HARP: only arthroscopic surgery
Other Name: Sham Surgery

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hip pain during daily and/or spor t ing activities;
  • intra-articular hip pain with radiological signs of FAI and/or labral tears eligible for hip arthroscopy (to be determined in a pragmatic fashion by the surgeon based on clinical examination and imaging
  • the patient is able to give written informed consent and to participate fully in the interventions and follow-up procedures

Exclusion Criteria:

  • pain that is not confirmed by physical examination of the hip
  • evidence of preexisting osteoarthritis, defined as Tonnis grade >1, or less than 3mm superior joint space width on AP pelvic radiograph
  • center edge angle on radiograph <25°; (v) previous known hip pathology such as Perthes' disease, slipped upper femoral epiphysis or avascular necrosis
  • previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture
  • previous hip surgery
  • medical conditions complicating surgery (ASA 3); (ix) inflammatory joint disease (RA, Bechterew etc)
  • physical inability to undertake testing procedures
  • expected lack of compliance such as cognitive impairment, drug abuse or similar;
  • inability to understand the written and spoken language of the treatment centre;
  • contra-indications to placebo surgery, which will include large loose body, chondral flap >1cm2 detached at 3 sides, complete labral radial flap tear and labral bucket-handle tear with complete avulsion >1.5cm long
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692807


Contacts
Contact: May Arna Risberg, PT, PhD 4741312776 m.a.risberg@nih.no
Contact: Agnethe Nilstad, PT, PhD 4799224469 agnethe.nilstad@nih.no

Locations
Australia, Victoria
LaTrobe University, School Allied Health, College of Science, Helath and Engineering Recruiting
Melbourne, Victoria, Australia, 3086
Contact: Kay Crossley, PT, PHD    +61411055738    k.crossley@latrobe.edu.au   
Principal Investigator: Joanne Kemp, PT, PHD         
Norway
Division of Orthopedic Surgery, Oslo University Hospital Recruiting
Oslo, Norway, 4956
Contact: Sverre Loken, MD, PhD    +4790704448    s-loek@online.no   
Contact: Tom Ludvigsen, MD    +4790642130    tomcl@getmail.no   
Sponsors and Collaborators
Oslo University Hospital
La Trobe University
University of Aarhus
Lund University
University of Oxford
University of Ottawa
Investigators
Principal Investigator: May Arna Risberg, PT, PhD Oslo University Hospital
Study Director: Lars Nordsletten, MD, PhD Oslo University Hospital
  More Information

Responsible Party: May Arna Risberg, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02692807     History of Changes
Other Study ID Numbers: NAR-1- 2016
2015091 ( Other Grant/Funding Number: South-Eastern Norway Regional Health Authority )
First Submitted: February 15, 2016
First Posted: February 26, 2016
Last Update Posted: May 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared across the sites participating in the HIPARTI and the HARP Study, according to the protocol and the decisions made by the Advisory Committee

Keywords provided by May Arna Risberg, Oslo University Hospital:
hip arthroscopy
femoroacetabular impingement
exercise therapy after hip arthroscopy
rehabilitation after hip arthroscopy

Additional relevant MeSH terms:
Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes