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The John Insall Award: no functional advantage of a mobile bearing posterior stabilized TKA.

ABSTRACT: Mobile bearing (MB) total knee design has been advocated as a means to enhance the functional characteristics and decrease the wear rates of condylar total knee arthroplasty (TKA). However, it is unclear if these designs achieve these goals.We asked whether function of patients or survivorship would be greater or complications would be lesser in groups of patients with MB compared with fixed bearing (FB) TKA. We also sought to describe retrieval findings.We randomized 507 primary TKAs in 416 eligible patients to receive MB (n = 252) or FB (n = 255) devices from November 2001 to August 2007 (Investigational Device Exemption G000180, ClinicalTrials.gov registration number NCT00946075). Patients were blinded to treatment allocation. WOMAC Index, SF-12 Health Survey, knee range of motion, and Knee Society scores were collected and compared preoperatively and at 6, 12, and 24 months postoperatively. We recorded device failures and complications until October 2009. Kaplan-Meier survivorship was compared using the log rank test. Twelve retrieved MB devices underwent pathologic analysis. The minimum postoperative time was 2.2 years (mean, 5.9 years; range, 2.2-7.9 years).We found no differences in mean clinical assessment scores or mean score changes from baseline at any postoperative interval through 2 postoperative years. Nineteen of the 252 MB and 13 of the 255 FB knees had undergone revision of any component. Estimated survival at 6 postoperative years was similar for the two devices: 90.1% (95% confidence interval [CI], 84.1-93.9) for MB and 94.2% (95% CI, 90.1-96.6) for FB. Two MB and no FB tibial components were revised for loosening. There was one case of MB insert dislocation. Retrieved MB devices demonstrated no unexpected wear or mechanical device failures.We found no evidence of functional advantage of the MB design. Survivorship was similar, although the study is limited by short duration of followup.

SUBMITTER: Mahoney OM

PROVIDER: S-EPMC3238000 | biostudies-literature | 2012 Jan

REPOSITORIES: biostudies-literature

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The John Insall Award: no functional advantage of a mobile bearing posterior stabilized TKA.

Mahoney Ormonde M OM Kinsey Tracy L TL D'Errico Theresa J TJ Shen Jianhua J

Clinical orthopaedics and related research 20120101 1

<h4>Background</h4>Mobile bearing (MB) total knee design has been advocated as a means to enhance the functional characteristics and decrease the wear rates of condylar total knee arthroplasty (TKA). However, it is unclear if these designs achieve these goals.<h4>Questions/purposes</h4>We asked whether function of patients or survivorship would be greater or complications would be lesser in groups of patients with MB compared with fixed bearing (FB) TKA. We also sought to describe retrieval find ...[more]

PMID: 22006197

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Project description:BackgroundIn primary TKA, prophylaxis with low-dose vancomycin through intraosseous regional administration (IORA) achieves tissue concentrations six to 10 times higher than systemic administration and was shown to provide more effective prophylaxis in an animal model. However, in revision TKA, the presence of a tibial implant may compromise IORA injection, and tourniquet deflation during a prolonged procedure may lower tissue concentrations.Questions/purposes(1) Does low-dose IORA reliably provide equal or higher tissue concentrations of vancomycin compared with systemic IV administration in revision TKA? (2) Are tissue concentrations of vancomycin after IORA maintained for the duration of the revision TKA despite a period of tourniquet deflation? (3) Is there any difference in early postoperative (< 6 weeks) complications between IORA and systemic IV administration in revision TKA?MethodsTwenty patients undergoing aseptic revision TKA were randomized to two groups. The IV group received 1 g systemic IV prophylactic vancomycin. The IORA group received 500 mg vancomycin as a bolus injection into a tibial intraosseous cannula below an inflated thigh tourniquet before skin incision. In all patients receiving IORA, intraosseous tibial injection was technically possible despite the presence of a tibial implant. Mean procedure length was 3.5 hours in both groups. Mean initial tourniquet inflation was 1.5 hours with a second inflation for a mean of 35 minutes during cementation. During the procedure, subcutaneous fat and bone samples were taken at regular intervals. Tissue vancomycin concentrations were measured using high-performance liquid chromatography.ResultsOverall geometric mean tissue concentration of vancomycin in fat samples was 3.7 μg/g (95% confidence interval [CI], 2.6-5.2) in the IV group versus 49.3 μg/g in the IORA group (95% CI, 33.2-73.4; ratio between means 13.5; 95% CI, 8.2-22.0; p < 0.001); mean tissue concentrations in femoral bone were 6.4 μg/g (95% CI, 4.5-9.2) in the IV group versus 77.1 μg/g (95% CI, 42.4-140) in the IORA group (ratio between means 12.0; 95% CI, 6.2-23.2; p < 0.001). Vancomycin concentrations in the final subcutaneous fat sample taken before closure were 5.3 times higher in the IORA group versus the IV group (mean ± SD, 18.2 ± 11.6 μg/g IORA versus 3.6 ± 2.5 μg/g; p < 0.001). The intraarticular concentration of vancomycin on postoperative Day 1 drain samples was not different between the two groups with the numbers available (mean 4.6 μg/L in the IV group versus 6.6 μg/g in the IORA group; mean difference 2.0 μg/g; 95% CI, 6.2-23.2; p = 0.08).ConclusionsIORA administration of vancomycin in patients undergoing revision TKA resulted in tissue concentrations of vancomycin five to 20 times higher than systemic IV administration despite the lower dose. High tissue concentrations were maintained throughout the procedure despite a period of tourniquet deflation. These preliminary results justify prospective cohort studies, which might focus on broader safety endpoints in more diverse patient populations. We believe that these studies should evaluate patients undergoing revision TKA in particular, because the risk of infection is greater than in patients undergoing primary TKA.Level of evidenceLevel I, therapeutic study.

Project description:BackgroundConcerns about the cost and convenience of postsurgical physical therapy (PT) have sparked interest in unsupervised, home-based rehabilitation. However, the effectiveness of unsupervised home exercise after primary TKA has not been previously evaluated.Questions/purposes(1) Can unsupervised home exercise after surgery provide noninferior recovery of passive knee flexion compared with formal outpatient PT? (2) Does a web-based platform for home-based exercise provide an advantage compared with a printed PT manual?MethodsWe conducted a randomized, noninferiority trial involving 290 patients (20% of the 1464 eligible patients who could be contacted) who underwent primary TKA from March 2016 to April 2018. We included patients > 18 years old who were undergoing primary, unilateral TKA and provided written consent. We excluded patients with preoperative knee flexion < 90°, patients considering surgical intervention in a hip or the contralateral knee, patients discharged to an extended care facility, and revision or conversion TKA. We randomized patients to one of three groups: outpatient PT, unsupervised home exercise using a web-based platform (web PT), or unsupervised home exercise using a printed paper manual (paper PT). We also implemented a "delayed recovery intervention" within the home exercise program, in which patients were obliged to begin outpatient PT if knee flexion was < 70° at 2 weeks or < 90° at 4 weeks. The primary outcome was change in knee flexion from preoperative baseline after 4 to 6 weeks and 6 months. Secondary outcomes included Knee Injury and Osteoarthritis Outcome Score (KOOS), time back to activities of daily living, and time off narcotics. All analyses were intention to treat, and the noninferiority margin was 5% with maximum flexion as the outcome of interest for this parameter.ResultsAdjusted differences in change in passive flexion for web PT +3° (95% confidence interval [CI], -1.2° to 6.4°) and paper PT +5° (95% CI, 0.99°-8.6°) were not inferior to outpatient PT based on a predefined 5° margin. Change in knee flexion from baseline was 0° for outpatient PT, -2° for web PT, and -1° for paper PT after 4 to 6 weeks and 8°, 8°, and 12° for the three groups, respectively, after 6 months. Additionally, there was no difference in the change in KOOS from baseline at 4 to 6 weeks or 6 months postoperatively as well as time back to work, driving, and walking without an assistive device.ConclusionsUnsupervised home exercise is an effective rehabilitation strategy after primary TKA and was noninferior to formal outpatient PT in selected patients. It is worthwhile to reconsider the current practice of automatically designating patients for outpatient PT after primary TKA, because appropriately selected patients with adequate clinical support can achieve similar results at home.Level of evidenceLevel I, therapeutic study.

Project description:BACKGROUND:The choice of surgical approach for THA remains controversial. Some studies suggest that the direct anterior approach (DAA) leads to less muscle damage than the miniposterior approach (MPA), but there is little high-quality evidence indicating whether this accelerates recovery, or whether this approach-which may be technically more demanding-is associated with component malposition or more complications. QUESTIONS/PURPOSES:(1) Does the DAA result in faster return to activities of daily living than the MPA? (2) Does the DAA have superior patient-reported outcome measures than the MPA? (3) Does the DAA result in improved radiographic outcomes than the MPA? (4) Does the DAA have a higher risk of complications than the MPA? METHODS:Between March 1, 2013, and May 31, 2016, 116 patients undergoing primary unilateral THA were randomized to either the DAA or MPA; 15 patients withdrew after randomization, and one died 6 months after surgery from a stroke unrelated to the procedure. Recruitment stopped when 52 patients had been randomized into the DAA group and 49 in the MPA group (n = 101). After patient randomization, one high-volume surgeon performed all of the DAAs and three high-volume surgeons performed the MPA THAs. The groups did not differ in age (65 years; SD 11; range, 38-86 years), sex (52% women), or body mass index (mean 29 kg/m; SD 6 kg/m; range, 21-40 kg/m; all p > 0.40). Functional results included time to discontinue gait aids, discontinue all narcotics, and independence with various activities of daily living; accelerometer data evaluated activity level. Clinical and radiographic outcomes, Hip disability and Osteoarthritis Outcome Score, SF-12, and Harris hip scores to 1 year were also tabulated. The minimum followup was 365 days (mean ± SD, 627 ± 369 days). RESULTS:There were slight differences in early functional recovery that favored the DAA versus the MPA: time to discontinue walker use (10 versus 15 days, p = 0.01) and time to discontinue all gait aids (17 versus 24 days, p = 0.04). There were no other differences in early functional milestones, although at 2 weeks after surgery, mean steps per day were 3897 (SD 2258; range, 737-11,010) for the DAA versus 2235 for the MPA (SD 1688; range, 27-7450; p < 0.01). There was no difference in activity monitoring at 1 year. There were no differences in patient-reported outcome scores between the groups. There was no difference in the radiographic parameters measured in the two groups, including leg length discrepancy, component position, or offset, and there was no subsidence observed in any hip. There was no difference in complications between the DAA and the MPA groups (8% [four of 52] versus 10% [five of 49]; p = 0.33). CONCLUSIONS:Both the DAA and MPA approaches provided excellent early recovery with a low risk of complications. Patients undergoing the DAA had a slightly faster recovery, as measured by milestones of function and quantified by activity monitor data, but no substantive differences were evident at 2 months. Because the DAA is the less studied approach, longer term (> 1 year) complications may yet accrue, will be important to quantify, and may offset early benefits. LEVEL OF EVIDENCE:Level I, therapeutic study.

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The John Insall Award: no functional advantage of a mobile bearing posterior stabilized TKA.

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The John Insall Award: no functional advantage of a mobile bearing posterior stabilized TKA.

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