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A RCT Comparing Hi-flex versus Standard Posterior Cruciate Substituting Polyethylene Tibial Inserts in TKR
Abstracts
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Paper #11 A RCT Comparing Hi-flex versus Standard Posterior Cruciate Substituting Polyethylene Tibial Inserts in TKR Richard W. McCalden, MD, Steven J. MacDonald, MD, Robert B. Bourne, MD, Juliana T. Marr, RN, BScN Introduction: The purpose of this study is to compare the range of motion (ROM) and clinical outcomes of a standard (PS) versus the high-flex (HF) polyethylene tibial insert of a posterior cruciate substituting total knee replacement system. Methods: One-hundred patients were entered into a prospective, blinded, RCT in which 50 patients received a Genesis II® PS insert and 50 patients received a Genesis II® HF insert. A single blinded observer measured ROM and clinical outcomes (WOMAC, SF-12 and the KSCRS) pre-operatively and post-operatively. In addition, patients were assessed for anterior knee pain using an analog scale. Results: No patients were lost to follow-up (two deaths < two years f/u). Ninety-eight patients were reviewed at an average follow-up of 2.7 years (range 2.3 – 3.1 years). There were no differences in any outcome measures. Specifically, there were no significant differences (p=0.611) in KSCRS at two years (Standard – 177±22, High Flex -177±24). There were no differences (p=0.811) in average knee flexion at 2 years (Standard– 123±7°, High Flex – 124±7°). Similarly, there were no differences in the change (pre-op to post-op) in any outcome measure or ROM between groups. Only 4 patients (2 HF, 2 PS) complained of anterior knee pain (range 1 to 7 out of 10). Conclusion: In this prospective blinded RCT, no differences in ROM or outcome scores could be seen between a PS and HF polyethylene design at a minimum of 2 years follow-up. Long-term evaluation will be required to comment on differences in polyethylene wear and implant longevity.
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Paper #11 A RCT Comparing Hi-flex versus Standard Posterior Cruciate Substituting Polyethylene Tibial Inserts in TKR Richard W. McCalden, MD, Steven J. MacDonald, MD, Robert B. Bourne, MD, Juliana T. Marr, RN, BScN Introduction: The purpose of this study is to compare the range of motion (ROM) and clinical outcomes of a standard (PS) versus the high-flex (HF) polyethylene tibial insert of a posterior cruciate substituting total knee replacement system. Methods: One-hundred patients were entered into a prospective, blinded, RCT in which 50 patients received a Genesis II® PS insert and 50 patients received a Genesis II® HF insert. A single blinded observer measured ROM and clinical outcomes (WOMAC, SF-12 and the KSCRS) pre-operatively and post-operatively. In addition, patients were assessed for anterior knee pain using an analog scale. Results: No patients were lost to follow-up (two deaths < two years f/u). Ninety-eight patients were reviewed at an average follow-up of 2.7 years (range 2.3 – 3.1 years). There were no differences in any outcome measures. Specifically, there were no significant differences (p=0.611) in KSCRS at two years (Standard – 177±22, High Flex -177±24). There were no differences (p=0.811) in average knee flexion at 2 years (Standard– 123±7°, High Flex – 124±7°). Similarly, there were no differences in the change (pre-op to post-op) in any outcome measure or ROM between groups. Only 4 patients (2 HF, 2 PS) complained of anterior knee pain (range 1 to 7 out of 10). Conclusion: In this prospective blinded RCT, no differences in ROM or outcome scores could be seen between a PS and HF polyethylene design at a minimum of 2 years follow-up. Long-term evaluation will be required to comment on differences in polyethylene wear and implant longevity.