ObjectivesPrimary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial.DesignA prospective blinded randomised controlled multicentre trial in patients with osteoarthritis of the hip. All patients, research assistants, clinical assessors, investigators and data analysts were blinded to the type of prosthesis. Population: 150 patients between 18 and 70 years with osteoarthritis of the hip, 75 in the short stem and 75 in the conventional stem group. Mean age: 60 years (SD 7). Interventions: the Collum Femoris Preserving short stem versus the Zweymuller Alloclassic conventional stem.Main outcome measuresThe Dutch version of the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes measures: Harris Hip Score, the Physical Component Scale of the SF12, the Timed Up and Go test, Pain and the EQ-5D. Feasibility outcomes: continued blinding, protocol adherence and follow-up success rate.ResultsNo significant difference between the two groups. Mean HOOS total score in the short stem group increased 32.7 points from 36.6 (95% CI 32.9 to 40.2) preoperatively to 69.3 (95% CI 66.4 to 72.1) at 3 months follow-up. Mean HOOS total score in the conventional straight stem group increased 36.3 points from 37.1 (95% CI 33.9 to 40.3) preoperatively to 73.4 (95% CI 70.3 to 76.4) at 3 months follow-up. 91.2% of patients remained blinded at 2 years follow-up. Both protocol adherence and follow-up success rate were 98%.ConclusionsFunctional result at 3 months and 2 years after short stem THA is not superior to conventional cementless THA. There were more perioperative and postoperative complications in the short stem group. Direct comparison of two hip implants in a double-blinded randomised controlled trial is feasible.Trial registration numberNTR1560.
Background: Two types of methods are used to assess learning curves: outcome assessment and process assessment. Outcome measures are usually dichotomous rare events like complication rates and survival or require an extensive follow-up and are therefore often inadequate to monitor individual learning curves. Time-action analysis (TAA) is a tool to objectively determine the level of efficiency of individual steps of a surgical procedure.
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.
Background Mid-term clinical results of uncemented femoral components with a Proplast coating have been unfavorable and the low modulus system was abandoned in the mid-1990s. There are, however, still substantial numbers of patients with a Proplast-coated prosthesis in situ. We evaluated the clinical and radiographic results in patients with 8-13 year follow-up.Methods We evaluated the survival rate, Harris Hip score and radiographic features of 82 hips in 69 patients. Mean age at operation was 58 (35-72) years.Results With respect to the Harris Hip score (HHS), 21% of the hips were considered to be clinical failures (HHS < 70) at final follow-up, mainly because of excessive thigh pain. Osteolysis was observed in one or more Gruen zones in one-third of the hips. According to the criteria of Engh, 79/82 stems were unstable. 11 hips were eventually revised due to aseptic loosening. Survival of the femoral component of the original cohort at final follow-up was 84% (95% CI: 75-93) in a standard-case scenario.Interpretation Extensive signs of loosening were observed in almost all hips, while not all hips were considered to be clinical failures. Thus, all patients should be thoroughly screened for radiographic progressive osteolysis or the occurrence of thigh pain. Thigh pain or progressive osteolysis warrants revision of the Proplastcoated femoral stem.
The aim of this study was to determine whether femoral neck preserving total hip arthroplasty would become less difficult and more efficient during the first 20 cases and to identify potential pitfalls during the introduction of this procedure. The difficulty and efficiency of the initial 20 procedures performed by four surgeons was prospectively determined by analysing a total of 68 video recordings using time-action analysis. This method measures the duration and efficiency of individual actions needed for a surgeon to achieve his or her goal. Afterwards, we reviewed all actions with a long duration and discussed possible causes of delay with the surgeons to identify possible pitfalls. We found a decrease of difficulty and an increase of efficiency during the first 20 cases and a more consistent execution after the initial five cases. Estimating the correct osteotomy level and stem curvature was often difficult, which resulted in a variable stem position. Radiologic analysis demonstrated a tendency for varus position and increased leg length throughout the series, even after the surgeons demonstrated technical proficiency.
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