Jan K G Louwerens1, Niels Hockers2, Gijs Achten2, Inger N Sierevelt2, Peter A Nolte2, Ruud P van Hove3. 1. Department of Orthopaedic Surgery, Spaarne Gasthuis Hospital, Hoofddorp, The Netherlands. jlouwerens@spaarnegasthuis.nl. 2. Department of Orthopaedic Surgery, Spaarne Gasthuis Hospital, Hoofddorp, The Netherlands. 3. Department of Orthopaedic Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
Abstract
PURPOSE: Improvement of biomechanical properties of cobalt-chromium-molybdenum (CoCrMo) implant surface and reduction of adhesive wear is achieved by titanium-nitride (TiN) coating in vitro. Less pain, higher postoperative outcome scores and a lower revision rate after TKA with a TiN-coated CoCrMo TKA compared with uncoated CoCrMo TKA after 10-year follow-up was hypothesized. METHODS: In a double-blinded RCT, 101 patients received a cementless mobile-bearing CoCrMo TKA, either TiN-coated or uncoated. The primary outcome measure was the visual analogue scale (VAS) score for pain and secondary outcome measures were the Knee Society Score (KSS), Oxford Knee Score (OKS), revision rate and adverse events. Patients were assessed at 6 weeks, 6 months, 1 year, 5 years and 10 years, postoperatively. RESULTS:68 patients (67%) were available for 10-year follow-up. No difference was found in any of the assessed outcome measures with a mean decrease in VAS score (31.6 ± 22.9) and a mean increase in OKS (10.9 ± 8.4), KSS (29.3 ± 31.4), KSSK (26.4 ± 18.2) and KSSF (4.1 ± 22.9). Overall revision rate was 7% (coated 6% vs uncoated 8%) without additional revision procedures between 5 and 10-year follow-up. CONCLUSIONS: The in vitro potential benefits of TiN coating did not result in better clinical outcome when compared to an uncoated cementless TKA. Pain, functional outcome and revision rates were comparable after 10-year follow-up. TiN-coated cementless TKA provides comparable good long-term results, similar to uncoated cementless CoCrMo TKA. LEVEL OF EVIDENCE: Level 1, Therapeutic Study NETHERLANDS TRIAL REGISTER: NL2887/NTR3033.
RCT Entities:
PURPOSE: Improvement of biomechanical properties of cobalt-chromium-molybdenum (CoCrMo) implant surface and reduction of adhesive wear is achieved by titanium-nitride (TiN) coating in vitro. Less pain, higher postoperative outcome scores and a lower revision rate after TKA with a TiN-coated CoCrMo TKA compared with uncoated CoCrMo TKA after 10-year follow-up was hypothesized. METHODS: In a double-blinded RCT, 101 patients received a cementless mobile-bearing CoCrMo TKA, either TiN-coated or uncoated. The primary outcome measure was the visual analogue scale (VAS) score for pain and secondary outcome measures were the Knee Society Score (KSS), Oxford Knee Score (OKS), revision rate and adverse events. Patients were assessed at 6 weeks, 6 months, 1 year, 5 years and 10 years, postoperatively. RESULTS: 68 patients (67%) were available for 10-year follow-up. No difference was found in any of the assessed outcome measures with a mean decrease in VAS score (31.6 ± 22.9) and a mean increase in OKS (10.9 ± 8.4), KSS (29.3 ± 31.4), KSSK (26.4 ± 18.2) and KSSF (4.1 ± 22.9). Overall revision rate was 7% (coated 6% vs uncoated 8%) without additional revision procedures between 5 and 10-year follow-up. CONCLUSIONS: The in vitro potential benefits of TiN coating did not result in better clinical outcome when compared to an uncoated cementless TKA. Pain, functional outcome and revision rates were comparable after 10-year follow-up. TiN-coated cementless TKA provides comparable good long-term results, similar to uncoated cementless CoCrMo TKA. LEVEL OF EVIDENCE: Level 1, Therapeutic Study NETHERLANDS TRIAL REGISTER: NL2887/NTR3033.
Entities:
Keywords:
Coating; Patient outcome assessment; Titanium–nitride; Total knee replacement