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.

BACKGROUND AND PURPOSE: To date, the mid- and long-term outcomes of the Collum Femoris Preserving (CFP) stem compared with conventional straight stems are unknown. We aimed to compare physical function at a 5-year follow-up and implant survival at an average of 10-year follow-up in an randomized controlled trial (RCT). METHODS: This is a secondary report of a double-blinded RCT in 2 hospitals. Patients aged 18-70 years with hip osteoarthritis undergoing an uncemented primary THA were randomized to a CFP or a Zweymüller stem. Patient-reported outcomes, clinical tests, and radiographs were collected at baseline, 2, 3, 4, and 5 years postoperatively. Primary outcome was the Hip disability and Osteoarthritis Outcome Score (HOOS) function in activities of daily living (ADL) subscale. Secondary outcomes were other patient-reported outcomes, clinical tests, adverse events, and implant survival. Kaplan-Meier and competing risk survival analyses were performed with data from the Dutch Arthroplasty Registry. RESULTS: We included 150 patients. Mean difference between groups on the HOOS ADL subscale at 5 years was -0.07 (95% confidence interval -5.1 to 4.9). Overall survival was 92% for the CFP and 96% for the Zweymüller stem. No significant difference was found. CONCLUSION: No significant differences were found in physical function at 5-year and implant survival at 10-year follow-up between the CFP and Zweymüller stems. When taking cup revisions into account, the CFP group showed clinically inferior survival.

Increased Persistent Mid-Thigh Pain After Short-Stem Compared With Wedge-Shaped Straight-Stem Uncemented Total Hip Arthroplasty at Medium-Term Follow-Up: A Randomized Double-Blinded Cross-Sectional Study.

BACKGROUND: Femoral prosthesis design may impact the frequency of mid-thigh pain. We compared current, incidental, and persistent mid-thigh pain between the short-stem, Collum Femoris femur prosthesis, and the wedge shaped straight-stem, Zweymüller femur prosthesis and studied the associations between demographics, radiographic measurements, and mid-thigh pain. METHODS: We contacted patients from a randomized controlled trial who underwent uncemented total hip arthroplasty (THA) for hip osteoarthritis at a mean follow-up of 44 months (range 24-64 months). Patients were specifically assessed for current (during assessment), incidental (any time postoperatively for >1 week) mid-thigh pain, and persistent (any time postoperatively for >2 years) mid-thigh pain. Furthermore, we used regression analysis to study associations between demographics, radiographic measurements, and mid-thigh pain. RESULTS: One hundred forty of 150 patients (93%) responded to our assessment. Mean age at the time of operation was 62 years (±7.0). Current mid-thigh pain occurred in 16 patients (23%) in the Collum Femoris Preserving (CFP) group compared with 10 patients (14%) in the Zweymüller group (P = .192). Incidental mid-thigh pain occurred in 24 patients (34%) in the CFP group compared with 15 patients (21%) in the Zweymüller group (P = .090). Persistent mid-thigh pain was found in 13 patients (19%) in the CFP group compared with five patients (7%) in the Zweymüller group (P = .043). Varus malalignment (odds ratio 1.819 [95% confidence interval 1.034-3.200]) and leg lengthening (odds ratio 1.107 per cm lengthening [95% confidence interval 1.026-1.195]) showed significant associations with mid-thigh pain. CONCLUSIONS: We found more persistent mid-thigh pain after short-stem uncemented THA compared to wedge-shaped straight-stem uncemented THA during medium-term follow-up. Varus malalignment and leg lengthening were associated with mid-thigh pain.

Cross-linked compared with historical polyethylene in THA: an 8-year clinical study.

UNLABELLED: Wear particle-induced osteolysis is a major cause of aseptic loosening in THA. Increasing wear resistance of polyethylene (PE) occurs by increasing the cross-link density and early reports document low wear rates with such implants. To confirm longer-term reductions in wear we compared cross-linked polyethylene (irradiation in nitrogen, annealing) with historical polyethylene (irradiation in air) in a prospective, randomized clinical study involving 48 patients who underwent THAs with a minimum followup of 7 years (mean, 8 years; range, 7-9 years). The insert material was the only variable. The Harris hip score, radiographic signs of osteolysis, and polyethylene wear were recorded annually. Twenty-three historical and 17 moderately cross-linked polyethylene inserts were analyzed (five patients died, three were lost to followup). At 8 years, the wear rate was lower for cross-linked polyethylene (0.088 +/- 0.03 mm/year) than for the historical polyethylene (0.142 +/- 0.07 mm/year). This reduction (38%) did not diminish with time (33% at 5 years). Acetabular cyst formation was less frequent (39% versus 12%), affected fewer DeLee and Charnley zones (17% versus 4%), and was less severe for the cross-linked polyethylene. The only revision was for an aseptically loose cup in the historical polyethylene group. Moderately cross-linked polyethylene maintained its wear advantage with time and produced less osteolysis, showing no signs of aging at mid-term followup. LEVEL OF EVIDENCE: Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

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.

OBJECTIVES: Primary 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. DESIGN: A 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 MEASURES: The 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. RESULTS: No 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%. CONCLUSIONS: Functional 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 NUMBER: NTR1560.

Curved versus Straight Stem Uncemented Total Hip Arthroplasty Osteoarthritis Multicenter trial (CUSTOM): design of a prospective blinded randomised controlled multicentre trial.

INTRODUCTION: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NTR1560.

Correlation of Technetium-99m scintigraphy, progressive acetabular osteolysis and acetabular component loosening in total hip arthroplasty.

In total hip arthroplasty (THA) Technetium scintigraphy can help to diagnose a loose implant by detecting elevated osteoblastic activity. It has been used for timing the revision of cemented implants. In uncemented cups progressive radiological acetabular osteolysis can be present before loosening accurs, but it is probably unwise to await cup loosening before embarking on revision. We explored the possible relationship between such osteolysis and positive findings on technetium scintigraphy, to see if the technique could predict the need for revision. Between 1990 and 1996 500 hydroxyapatite-coated hip prostheses were implanted (follow-up range: 9-15 years), and technetium scintigraphy and plain radiography were performed annually postoperatively. 32 cups were revised for progressive acetabular osteolysis. We compared the introperative findings at revision with the pre-operative scintigraphic and radiographic results. The sensitivity and specificity for diagnosing progressive acetabular osteolysis by technetium scintigraphy were 34% and 0% respectively. The sensitivity and specificity of the technique for detecting loosening were 38% and 73% respectively. The sensitivity and specificity of technetium scintigraphy for detection of a either loosening or progressive acetabular osteolysis are worse than reported for plain radiography. Despite negative scintigraphy, there may be progressive bone loss at a critical level. Scintigraphy has no additional value to plain radiography as a reliable indicator for timing cup revision in the process of progressive acetabular osteolysis.

Cementless hemispheric hydroxyapatite-coated sockets for acetabular revision.

This study describes our experience with a hydroxyapatite-coated uncemented hemispherical component used for revision of 72 patients with aseptic loosening of the acetabular component. Preoperative Paprosky classification of the acetabular defects was 1 type I, 35 type II, and 36 type III; according to American Academy of Orthopaedic Surgeons, 14 segmental, 10 cavitary, and 48 combined. The mean follow-up was 7.6 years (range, 5.0-13.0). Complications were seen in 7 cases (9.6%). Seventy acetabular components (97.2%) showed bone ongrowth on the radiographs. The survival rate was 90.8% after a mean follow-up of 7.6 years (range, 5.0-13.0) when revision for any reason is the end point (confidence interval, 80.5%-100%) and 98.1% (confidence interval, 94.5%-100%) when aseptic loosening of the cup is the end point. We conclude that hydroxyapatite-coated cups for acetabular revision show promising results.

Crosslinked polyethylene compared to conventional polyethylene in total hip replacement: pre-clinical evaluation, in-vitro testing and prospective clinical follow-up study.

BACKGROUND: Polyethylene wear-induced osteolysis is a major cause of implant loosening in total hip arthroplasty. New crosslinked polyethylenes are presumed to give lower wear rates, but no long-term clinical results are available yet. PATIENTS AND METHODS: We compared basic material characteristics and MTS hip joint simulator wear rates of a crosslinked polyethylene (Duration) to those of conventional polyethylene. In a randomized double-blind 5-year clinical follow-up study, 133 hips (67 conventional, 66 Duration) in 127 patients were followed-up for an average of 5 (3-6) years. Wear rates were measured using a computer-based edge detection method. The radiographic appearances of wear-related phenomena were recorded. RESULTS: The Duration polyethylene showed a significantly lower in-vitro wear rate in the simulator study (mean 22 (SD 2.3) vs. 40 (SD 1.5) mm3/106 cycles). Also, the in-vivo wear was lower for Duration (mean 0.083 (SD 0.056) mm/year) than for conventional polyethylene (mean 0.123 (SD 0.082) mm/year). All radiographic signs of osteolysis were less frequent in the Duration group. INTERPRETATION: Our study has given a substantial body of evidence--from lower wear rates, less frequent signs of osteolysis, and higher survival rates after a mean follow-up of 5 years--that Duration provides better clinical outcomes than conventional polyethylene.