Curved versusStraight Stem UncementedTotal Hip ArthroplastyOsteoarthritisMulticenter trial (CUSTOM): design of a prospective blinded randomised controlled multicentre trial

Abstract

IntroductionAnswering 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.MethodsA 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.Ethics and disseminationThis 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.ResultsResults will be submitted for publication to an orthopaedics related journal.Trial registration numberNTR1560.

Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip

“…gov/ pmc/ articles/ PMC4809092/. 35 We used stratified block randomisation consisting of a random sequence of blocks of 10 consecutive surgical procedures each. Randomisation was performed in the operating theatre, after anaesthetic induction and just before incision, using a sequentially numbered opaque sealed envelope.…”

“…Publication bias was prevented by publishing the protocol. 35 Deblinded patients, withdrawals and protocol deviations were included in the intention-to-treat analysis.…”

Short versus conventional straight stem in uncemented total hip arthroplasty: functional outcomes up to 5 years and survival up to 12 years: secondary results of a randomized controlled trial

“…This is similar to our 2-year results [ 9 ] and to the vast majority of randomized trials in the primary THA population [ 25 ]. We used a rather conservative threshold for clinical relevance for the primary outcome: a difference of 10% [ 7 , 26 ]. At 5-year follow-up, the difference for HOOS ADL was 2.9%.…”

“…We performed a double-blinded RCT in 2 general hospitals in the Netherlands. The protocol and the 2-year results have been published [ 7 , 9 ].…”

“…In 2009 we initiated the CUSTOM trial; the first randomized clinical trial (RCT) to compare the CFP with a conventional uncemented straight Zweymüller Alloclassic stem (Zimmer Biomet, Warsaw, IN, USA) [ 7 ]. The primary aim was to compare the functional results of these stems at 3 months and 2 years postoperatively.…”