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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)

Risberg, May Arna; Ageberg, Eva LU ; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; LØken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha and Kostogiannis, Ioannis LU , et al. (2018) In Journal of Orthopaedic and Sports Physical Therapy 48(4). p.325-335
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 patient-reported 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).... (More)

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 patient-reported 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 degenrative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined.

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publication status
published
subject
keywords
Acetabular labral tear, Cam, FAI, Hip arthroscopy, Outcome, Pincer, Placebo
in
Journal of Orthopaedic and Sports Physical Therapy
volume
48
issue
4
pages
11 pages
publisher
J O S P T, Alliance Group Communications
external identifiers
  • scopus:85044725765
ISSN
0190-6011
DOI
10.2519/jospt.2018.7931
language
English
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yes
id
6967a5d3-f680-4f0c-9d77-af085ac55920
date added to LUP
2018-04-10 13:10:54
date last changed
2019-11-13 05:05:25
@article{6967a5d3-f680-4f0c-9d77-af085ac55920,
  abstract     = {<p>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 patient-reported 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 degenrative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined.</p>},
  author       = {Risberg, May Arna and Ageberg, Eva and Nilstad, Agnethe and Lund, Bent and Nordsletten, Lars and LØken, Sverre and Ludvigsen, Tom and Kierkegaard, Signe and Carsen, Sasha and Kostogiannis, Ioannis and Crossley, Kay M. and Glyn-Jones, Sion and Kemp, Joanne L.},
  issn         = {0190-6011},
  keyword      = {Acetabular labral tear,Cam,FAI,Hip arthroscopy,Outcome,Pincer,Placebo},
  language     = {eng},
  month        = {04},
  number       = {4},
  pages        = {325--335},
  publisher    = {J O S P T, Alliance Group Communications},
  series       = {Journal of Orthopaedic and Sports Physical Therapy},
  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)},
  url          = {http://dx.doi.org/10.2519/jospt.2018.7931},
  volume       = {48},
  year         = {2018},
}