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- Title
Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).
- Authors
RISBERG, MAY ARNA; AGEBERG, EVA; NILSTAD, AGNETHE; LUND, BENT; NORDSLETTEN, LARS; LØKEN, SVERRE; LUDVIGSEN, TOM; KIERKEGAARD, SIGNE; CARSEN, SASHA; KOSTOGIANNIS, IOANNIS; CROSSLEY, KAY M.; GLYN-JONES, SION; KEMP, JOANNE L.
- Abstract
* STUDY DESIGN: Study protocol for a randomized controlled trial and a prospective cohort. * BACKGROUND: The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. * OBJECTIVES: The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patientreported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). * METHODS: The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. * CONCLUSION: To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined.
- Subjects
TREATMENT effectiveness; ARTHROSCOPY; EXPERIMENTAL design; HIP joint injuries; LONGITUDINAL method; RESEARCH methodology; STATISTICS; DATA analysis; RANDOMIZED controlled trials; HUMAN research subjects; FEMORACETABULAR impingement
- Publication
Journal of Orthopaedic & Sports Physical Therapy, 2018, Vol 48, Issue 4, p325
- ISSN
0190-6011
- Publication type
Article
- DOI
10.2519/jospt.2018.7931