title: Curved versus Straight Stem Uncemented Total Hip Arthroplasty Osteoarthritis Multicenter trial (CUSTOM): design of a prospective blinded randomised controlled multicentre trial.
abstract: BACKGROUND
  Answering the demands of an increasingly young and active patient population, recent developments in total hip arthroplasty (THA) have shifted towards minimising tissue damage. The Collum Femoris Preserving (CFP) stem was developed to preserve the trochanteric region of the femur, which potentially preserves the insertion of the gluteus musculature. This might accelerate early postoperative rehabilitation and improve functional outcome. Currently the functional results of the CFP stem have not been compared with conventional straight stems in a randomised controlled trial (RCT). The primary purpose of this trial is to compare the functional result of CFP stem THA with conventional uncemented straight stem THA, measured by the Dutch Hip disability and Osteoarthritis Outcome Score (HOOS) at 3-month follow-up.
  
  
  METHODS
  A prospective blinded multicentre RCT will be performed. We aim to recruit 150 patients. The patients will be randomly allocated to a THA with a straight or a curved stem. All patients, research assistants, clinical assessors and investigators will be blinded for the type of prosthesis for 5 years. Clinical assessments and roentgenograms will be taken preoperative, at 6 weeks after surgery, at 1, 2, 3, 4 and 5 years after surgery. Patient reported outcome measures (PROMs) will be obtained at the same follow-up moments. In addition, the PROMs will also be sent to the patients at 3 and 6 months after surgery. The HOOS at 3-month follow-up will be our primary outcome.
  
  
  BACKGROUND
  This trial will be performed in accordance with the Declaration of Helsinki. A local ethics committee has approved this trial. Written informed consent will be obtained from all participating patients. All serious adverse events will be reported to the ethics committee.
  
  
  RESULTS
  Results will be submitted for publication to an orthopaedics related journal.
  
  
  BACKGROUND
  NTR1560.
authors.affiliation: Department of Orthopaedic Surgery, Joint Research, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, The Netherlands.
authors.forename: Loes W A H
authors.initials: LW
authors.lastname: van Beers
authors.affiliation: Department of Orthopaedic Surgery, Academic Medical Center (AMC), Amsterdam, The Netherlands.
authors.forename: Jakob
authors.initials: J
authors.lastname: van Oldenrijk
authors.affiliation: Department of Orthopaedic Surgery, Joint Research, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, The Netherlands.
authors.forename: Vanessa A B
authors.initials: VA
authors.lastname: Scholtes
authors.affiliation: Department of Orthopaedic Surgery, Ikazia Hospital, Rotterdam, The Netherlands.
authors.forename: Carel H
authors.initials: CH
authors.lastname: Geerdink
authors.affiliation: Department of Orthopaedic Surgery, Ikazia Hospital, Rotterdam, The Netherlands.
authors.forename: Bob B A M
authors.initials: BB
authors.lastname: Niers
authors.affiliation: Department of Orthopaedic Surgery, Joint Research, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, The Netherlands.
authors.forename: Wouter
authors.initials: W
authors.lastname: Runne
authors.affiliation: Department of Surgery, McMaster University Hospital, Hamilton, Ontario, Canada.
authors.forename: Mohit
authors.initials: M
authors.lastname: Bhandari
authors.affiliation: Department of Orthopaedic Surgery, Joint Research, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, The Netherlands.
authors.forename: Rudolf W
authors.initials: RW
authors.lastname: Poolman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005269:Femur / Q000601:surgery*; D006615:Hip / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D015207:Osteoarthritis, Hip / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
keywords: ORTHOPAEDIC & TRAUMA SURGERY