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Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomized controlled equivalence trial of 125 mm versus 150 mm Exeter V40 stems in total hip arthroplasty.

ABSTRACT: BACKGROUND:The use of shorter length femoral stems during total hip arthroplasty has been suggested to accommodate wider patient femoral geometry and offer maximal bone preservation. However, cemented short-stem designs may increase the risk of varus stem malalignment and influence patient outcomes. METHODS/DESIGN:CASINO is a multi-centre randomised equivalence trial that will recruit 220 patients undergoing total hip arthroplasty for osteoarthritis at two NHS hospitals in Scotland. Patients will be aged 45-80, undergoing unilateral primary hip arthroplasty, with no plan for contralateral procedure within the study timeframe, and able to comply with the protocol. Participants will be randomised to receive either a short (125 mm) or a standard (150 mm) Exeter V40 stem. The Contemporary acetabular component will be used in all cases. All implants will be cemented. Patient pain, function and satisfaction will be assessed using change from baseline measurement in Oxford Hip Score, Forgotten Joint Score, EQ-5D, pain numerical rating scores, and patient satisfaction questionnaire at baseline and at 1 and 2 years following surgery. Radiographic assessment will evaluate stem position and will be appraised by independent reviewers. Patients will be blind to implant allocation. DISCUSSION:Stem length may be associated with outcome; however, we can find no randomised trial in which researchers investigated the effect of stem length on patient outcome following cemented total hip arthroplasty. The aim of this trial is to determine if the use of short cemented stems offers equivalent patient outcomes to those achieved following surgery with standard length stems. TRIAL REGISTRATION:International Standard Randomised Controlled Trial Number, ISRCTN13154542 , Registered on 30 June 2017.

SUBMITTER: Hamilton DF

PROVIDER: S-EPMC5903002 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomized controlled equivalence trial of 125 mm versus 150 mm Exeter V40 stems in total hip arthroplasty.

Hamilton David F DF Ohly Nicholas E NE Gaston Paul P

Trials 20180416 1

<h4>Background</h4>The use of shorter length femoral stems during total hip arthroplasty has been suggested to accommodate wider patient femoral geometry and offer maximal bone preservation. However, cemented short-stem designs may increase the risk of varus stem malalignment and influence patient outcomes.<h4>Methods/design</h4>CASINO is a multi-centre randomised equivalence trial that will recruit 220 patients undergoing total hip arthroplasty for osteoarthritis at two NHS hospitals in Scotlan ...[more]

PMID: 29661229

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Project description:AimsThe Exeter short stem was designed for patients with Dorr type A femora and short-term results are promising. The aim of this study was to evaluate the minimum five-year stem migration pattern of Exeter short stems in comparison with Exeter standard stems.MethodsIn this case-control study, 25 patients (22 female) at mean age of 78 years (70 to 89) received cemented Exeter short stem (case group). Cases were selected based on Dorr type A femora and matched first by Dorr type A and then age to a control cohort of 21 patients (11 female) at mean age of 74 years (70 to 89) who received with cemented Exeter standard stems (control group). Preoperatively, all patients had primary hip osteoarthritis and no osteoporosis as confirmed by dual X-ray absorptiometry scanning. Patients were followed with radiostereometry for evaluation of stem migration (primary endpoint), evaluation of cement quality, and Oxford Hip Score. Measurements were taken preoperatively, and at three, 12, and 24 months and a minimum five-year follow-up.ResultsAt three months, subsidence of the short stem -0.87 mm (95% confidence interval (CI) -1.07 to -0.67) was lower compared to the standard stem -1.59 mm (95% CI -1.82 to -1.36; p < 0.001). Both stems continued a similar pattern of subsidence until five-year follow-up. At five-year follow-up, the short stem had subsided mean -1.67 mm (95% CI -1.98 to -1.36) compared to mean -2.67 mm (95% CI -3.03 to -2.32) for the standard stem (p < 0.001). Subsidence was not influenced by preoperative bone quality (osteopenia vs normal) or cement mantle thickness.ConclusionThe standard Exeter stem had more early subsidence compared with the short Exeter stem in patients with Dorr type A femora, but thereafter a similar migration pattern of subsidence until minimum five years follow-up. Both the standard and the short Exeter stems subside. The standard stem subsides more compared to the short stem in Dorr type A femurs. Subsidence of the Exeter stems was not affected by cement mantle thickness.

Project description:BackgroundThe introduction of new devices for total hip arthroplasty (THA) offers surgeons the ability to address deficits in the portfolio. However, once introduced, data regarding the performance of devices is not publicly available until their use is widespread.Purpose/questionsThe objective of this study was to compare the clinical and radiographic performance, including patient reported outcomes and radiographic evidence of osseointegration, subsidence, and stress shielding, of the newer Actis femoral component to the Corail stem (DePuy Synthes, Warsaw, IN, USA), which has an extensive clinical history.MethodsThis short-term, retrospective cohort study was a single surgeon series of 330 anterior approach THAs, consisting of 165 cases using the Actis stem and 165 cases using the Corail stem. Both devices were cementless, titanium, tapered, hydroxyapatite-coated stems. They differed in geometry, neck choices, broach philosophy, and collar availability. Data was obtained for 1 year following THA. Functional outcomes were measured with the Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.) survey. Complications were recorded from patient charts, and radiographic analysis was performed for signs of osseointegration, subsidence, and stress shielding.ResultsThe groups shared similar demographic characteristics except the Actis population was younger with fewer women. The complication rate did not significantly vary, and no patient required revision within the first year. Radiographically, one patient in each group demonstrated subsidence. No cases exhibited radiolucent lines, and the prevalence of stress shielding at 1 year was comparable. HOOS, JR. scores did not significantly vary at 8 weeks or 1 year.ConclusionThe Actis stem does not carry an increased risk of device-related complications compared with the Corail implant. Although aspects of bone remodeling differed between groups, Actis achieved radiographic signs of bone ingrowth at the 1-year mark and performed well clinically, with equivalent patient reported outcome scores to the Corail stem.

Project description:BackgroundThe standard Exeter (Stryker) cemented stem is 150 mm long with standard offsets ranging from 37.5 mm to 56 mm. Exeter short stems of 125 mm are also available in the offsets of 37.5 mm, 44 mm, and 50 mm. In addition, smaller (125 mm or shorter) Exeter cemented stems with offsets of 35.5 mm or less are available. The aim of this study was to examine the New Zealand Joint Registry (NZJR) comparing medium-term survival rates and functional outcomes of standard-length stems with Exeter short stems of various offsets in patients undergoing primary total hip replacement.MethodsUsing the NZJR, we compared the results of 3 separate groups of patients with Exeter stems. Patients with standard 150 mm length Exeter stems (Standard) were compared with patients with Exeter 125 mm stems with regular 37.5 mm, 44 mm, and 50 mm offsets (Short 37+) and Exeter 125 mm stems with offsets of 35.5 mm and below (Short 37-). Demographic data, preoperative diagnosis, patient-reported outcome measures, and reasons for revision were compared between groups. Kaplan-Meier survival analysis and Cox multivariate regression analysis were used to examine implant survival and the influence of stem group on revision rates adjusting for gender, age, diagnosis, and surgical approach.ResultsThere were 43,427 Exeter cemented stems in the NZJR between January 1, 1999 and 31, May 2018; 41,629 Standard, 657 Short 37+, and 1501 Short 37-. In all 3 groups, the posterior surgical approach was preferred (Standard, 76.1%; Short 37+, 94.6%; Short 37-, 76.6%; P < .001). In the Short 37- group, 94.1% were female, while in the other 2 groups, there was an equal gender ratio (P < .001). The Short 37- group was also significantly younger than the other 2 groups with 41.6% younger than 65 years compared with Short 37+ (37.2%) and Standard groups (36.9%) (P < .01). There was no difference in American Society of Anesthesiologists grade between groups. Body mass index (BMI) was significantly higher in both the Short 37- and Short 37 + groups compared with the Standard group (Standard BMI, 28.71; SD 5.72; Short 37+ BMI, 29.69; SD, 6.67; Short 37- BMI, 29.09; SD 7.07; P < .001). The all-cause revision rate for standard stems was 0.55/100 component years (cy) (95% CI: 0.52 to 0.58). The Short 37- group had a higher rate of revision compared with the Standard group (hazard ratio 1.6; 95% CI: 1.3 to 1.98; P < .001), while the Short 37+ group had a hazard ratio of 0.84 (95% CI: 0.38 to 1.88; P = .674) compared with the Standard group. Cox regression analysis controlling for age, gender, diagnosis of OA, and surgical approach did not affect these findings. However, no clinically meaningful difference between Oxford hip scores was observed.ConclusionsThere was a significant difference in revision rates for aseptic loosening with standard-length Exeter stems having a lower revision rate than short Exeter stems with offsets 35.5 mm or less. The Short 37+ groups, despite comprising relatively small numbers, performed similarly to the Standard stem group.

Project description:BackgroundBoth modular and monoblock tapered fluted titanium (TFT) stems are increasingly being used for revision total hip arthroplasty (rTHA). However, the differences between the two designs in clinical outcomes and complications are not yet clear. Here, we intend to compare the efficacy and safety of modular versus monoblock TFT stems in rTHA.MethodsPubMed, Embase, Web of Science, and Cochrane Library databases were searched to include studies comparing modular and monoblock implants in rTHA. Data on the survivorship of stems, postoperative hip function, and complications were extracted following inclusion criteria. Inverse variance and Mantel-Haenszel methods in Review Manager (version 5.3 from Cochrane Collaboration) were used to evaluate differences between the two groups.ResultsTen studies with a total of 2188 hips (1430 modular and 758 monoblock stems) were finally included. The main reason for the revision was aseptic loosening. Paprosky type III was the most common type in both groups. Both stems showed similar re-revision rates (modular vs monoblock: 10.3% vs 9.5%, P = 0.80) and Harris Hip Scores (WMD = 0.43, P = 0.46) for hip function. The intraoperative fracture rate was 11.6% and 5.0% (P = 0.0004) for modular and monoblock stems, respectively. The rate of subsidence > 10 mm was significantly higher in the monoblock group (4.5% vs 1.0%, P = 0.003). The application of extended trochanteric osteotomy was more popular in monoblock stems (22.7% vs 17.5%, P = 0.003). The incidence of postoperative complications such as periprosthetic femoral fracture and dislocation was similar between both stems.ConclusionsNo significant difference was found between modular and monoblock tapered stems as regards postoperative hip function, re-revision rates, and complications. Severe subsidence was more frequent in monoblock stems while modular ones were at higher risk of intraoperative fracture.Level of evidenceLevel III, systematic review of randomized control and non-randomized studies.Trial registrationWe registered our study in the international prospective register of systematic reviews (PROSPERO) (CRD42020213642).

Dataset Information

Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomized controlled equivalence trial of 125 mm versus 150 mm Exeter V40 stems in total hip arthroplasty.

Publications

Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomized controlled equivalence trial of 125 mm versus 150 mm Exeter V40 stems in total hip arthroplasty.

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