Computer-Assisted Compared with Conventional Total Knee Replacement: A Multicenter Parallel-Group Randomized Controlled Trial.

BACKGROUND: We previously reported the short-term radiographic and functional results of a randomized controlled trial (RCT) comparing computer-assisted and conventionally performed total knee replacement. We currently report the 2-year clinical results from this trial. METHODS: One hundred and ninety patients were randomly allocated to undergo either computer-assisted or conventional total knee replacement. One hundred and seventy-two patients were available for clinical evaluation at 2 years, and 167 (97%) of those answered all patient-reported outcome measures (PROMs), including the Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Society Score (KSS), visual analog scale (VAS), and EuroQol-5 Dimensions (EQ-5D). Patients and clinical evaluators were blinded to the method of surgery. Surgical outcome was assessed using the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) criteria to calculate responder rates, divided into high responders, moderate responders, and nonresponders. RESULTS: The computer-assisted group had significantly more improvement than the conventional group in the mean scores for 2 subscales of the KOOS (7.4 for symptoms [p = 0.02] and 16.2 for sport and recreation [p < 0.01]) and in 1 subscale of the WOMAC (8.8 for stiffness [p = 0.03]).The computer-assisted group also had significantly more high responders (82.8%) than the conventional group (68.8%; p = 0.03) at 2 years, with the number needed to treat determined to be 8. CONCLUSIONS: In this study, the use of computer navigation provided better pain relief and restored better function than the use of the conventional surgical technique at 2 years after total knee replacement. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Similar migration in computer-assisted and conventional total knee arthroplasty.

Background and purpose - Computer-assisted surgery (CAS) in total knee arthroplasty (TKA) has been used in recent years in the hope of improving the alignment and positioning of the implant, thereby achieving a better functional outcome and durability. However, the role of computer navigation in TKA is still under debate. We used radiostereometric analysis (RSA) in a randomized controlled trial (RCT) to determine whether there are any differences in migration of the tibial component between CAS- and conventionally (CONV-) operated TKA. Patients and methods - 54 patients (CAS, n = 26; CONV, n = 28) with a mean age of 67 (56-78) years and with osteoarthritis or arthritic disease of the knee were recruited from 4 hospitals during the period 2009-2011. To estimate the mechanical stability of the tibial component, the patients were examined with RSA up to 24 months after operation. The following parameters representing tibial component micromotion were measured: 3-D vector of the prosthetic marker that moved the most, representing the magnitude of migration (maximum total point motion, MTPM); the largest negative value for y-translation (subsidence); the largest positive y-translation (lift-off); and prosthetic rotations. The precision of the RSA measurements was evaluated and migration in the 2 groups was compared. Results - Both groups had most migration within the first 3 months, but there was no statistically significant difference in the magnitude of the migration between the CAS group and the CONV group. From 3 to 24 months, the MTPM (in mm) was 0.058 and 0.103 (p = 0.1) for the CAS and CON groups, respectively, and the subsidence (in mm) was 0.005 and 0.011 (p = 0.3). Interpretation - Mean MTPM, subsidence, lift-off, and rotational movement of tibial trays were similar in CAS- and CONV-operated knees.

Better survival of hybrid total knee arthroplasty compared to cemented arthroplasty.

BACKGROUND AND PURPOSE: There have been few comparative studies on total knee replacement (TKR) with cemented tibia and uncemented femur (hybrid TKR). Previous studies have not shown any difference in revision rate between cemented and hybrid fixation, but these studies had few hybrid prostheses. We have evaluated the outcome of hybrid TKR based on data from the Norwegian Arthroplasty Register (NAR). PATIENTS AND METHODS: We compared 4,585 hybrid TKRs to 20,095 cemented TKRs with risk of revision for any cause as the primary endpoint. We included primary TKRs without patella resurfacing that were reported to the NAR during the years 1999-2012. To minimize the possible confounding effect of prosthesis brands, only brands that were used both as hybrids and cemented in more than 200 cases were included. Kaplan-Meier survival analysis and Cox regression analysis were done with adjustment for age, sex, and preoperative diagnosis. To include death as a competing risk, cumulative incidence function estimates were calculated. RESULTS: Estimated survival at 11 years was 94.3% (95% CI: 93.9-94.7) in the cemented TKR group and 96.3% (CI: 95.3-97.3) in the hybrid TKR group. The adjusted Cox regression analysis showed a lower risk of revision in the hybrid group (relative risk = 0.58, CI: 0.48-0.72, p < 0.001). The hybrid group included 3 brands of prostheses: LCS classic, LCS complete, and Profix. Profix hybrid TKR had lower risk of revision than cemented TKR, but the LCS classic and LCS complete did not. Kaplan-Meier estimated survival at 11 years was 96.8% (CI: 95.6-98.0) in the hybrid Profix group and 95.2% (CI: 94.6-95.8) in the cemented Profix group. Mean operating time was 17 min longer in the cemented group. INTERPRETATION: Survivorship of the hybrid TKR at 11 years was better than that for cemented TKR, or the same, depending on the brand of prosthesis. Hybrid fixation appears to be a safe and time-efficient alternative to cemented fixation in total knee replacement surgery.

Nonoperative treatment of the medial malleolus in bimalleolar and trimalleolar ankle fractures: a randomized controlled trial.

OBJECTIVES: To compare internal fixation with no fixation of the medial malleolus after open reduction and internal fixation of the lateral malleolus and if needed, the posterior malleolus. DESIGN: Randomized prospective trial. SETTING: Level III trauma center in a metropolitan area. PATIENTS: One hundred patients with bimalleolar or trimalleolar Orthopaedic Trauma Association type 44 ankle fractures and displacement of the medial malleolus less than 2 mm after open reduction and internal fixation of the lateral component. INTERVENTION: Internal fixation or nonoperative treatment of the medial malleolus. MAIN OUTCOME MEASUREMENTS: American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS), The Olerud Molander Ankle (OMA) score, and visual analogue pain scale (VAS). RESULTS: Median follow-up time was 39 months (range: 24-72). There were no significant differences between the 2 groups with respect to OMA (P = 0.91), AOFAS (P = 0.85), VAS (P = 0.85), or development of osteoarthritis (P = 0.22). Reoperation and complication rates were also comparable, but 4 patients treated nonoperatively developed nonunion of the medial malleolus. These patients reported no functional disabilities and presented OMA, AOFAS, and VAS scores better than average. CONCLUSIONS: Our data indicate that nonoperative treatment of minimally displaced fractures of the medial malleolus after operative fixation of the fibula yields satisfactory results. However, long-term follow-up is needed due to increased risk of nonunion and uncertainty regarding the development of posttraumatic arthritis. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Short-term outcome of 1,465 computer-navigated primary total knee replacements 2005-2008.

BACKGROUND: and purpose Improvement of positioning and alignment by the use of computer-assisted surgery (CAS) might improve longevity and function in total knee replacements, but there is little evidence. In this study, we evaluated the short-term results of computer-navigated knee replacements based on data from the Norwegian Arthroplasty Register. PATIENTS AND METHODS: Primary total knee replacements without patella resurfacing, reported to the Norwegian Arthroplasty Register during the years 2005-2008, were evaluated. The 5 most common implants and the 3 most common navigation systems were selected. Cemented, uncemented, and hybrid knees were included. With the risk of revision for any cause as the primary endpoint and intraoperative complications and operating time as secondary outcomes, 1,465 computer-navigated knee replacements (CAS) and 8,214 conventionally operated knee replacements (CON) were compared. Kaplan-Meier survival analysis and Cox regression analysis with adjustment for age, sex, prosthesis brand, fixation method, previous knee surgery, preoperative diagnosis, and ASA category were used. RESULTS: Kaplan-Meier estimated survival at 2 years was 98% (95% CI: 97.5-98.3) in the CON group and 96% (95% CI: 95.0-97.8) in the CAS group. The adjusted Cox regression analysis showed a higher risk of revision in the CAS group (RR = 1.7, 95% CI: 1.1-2.5; p = 0.02). The LCS Complete knee had a higher risk of revision with CAS than with CON (RR = 2.1, 95% CI: 1.3-3.4; p = 0.004)). The differences were not statistically significant for the other prosthesis brands. Mean operating time was 15 min longer in the CAS group. INTERPRETATION: With the introduction of computer-navigated knee replacement surgery in Norway, the short-term risk of revision has increased for computer-navigated replacement with the LCS Complete. The mechanisms of failure of these implantations should be explored in greater depth, and in this study we have not been able to draw conclusions regarding causation.