The purpose of this study was to assess the clinical and patient-reported outcomes of a customised, individually made (CIM) bi-compartmental knee arthroplasty (BKA).
A prospectively recruited cohort of 79 patients was implanted with a CIM-BKA (patello-femoral plus either medial or lateral tibio-femoral, iDuo G2 system, Conformis, Billerica MA) at eight centres in the US and Germany. Patients were assessed for the 2011 KSS, KOOS, and ROM pre-operatively and at 2 weeks, 6 weeks, 12 weeks, 1 year, and 2 years post-operatively.
The objective KSS score significantly improved from 69 at the pre-operative visit, to 94 at the 2-year post-operative time-point. Similar improvements were observed for the KSS function and satisfaction domains. Significant improvements from pre-operative levels were observed across all five domains of the KOOS. Two patients have undergone surgery to revise their CIM-BKA implant to total knees, resulting in a survivorship rate of 97.5% at an average follow-up of 2.6 years.
CIM-BKA compares favourably to published scores as well as revision rates for previously available monolithic OTS-BKA implants. CIM-BKA implants provide surgeons with a viable and patient-specific monolithic implant solution as an option for patients presenting with bi-compartmental disease, who might, otherwise, be treated by performing uni-condylar + patello-femoral joint or bicruciate sparing TKA surgeries. Longer follow-up and higher numbers have to be awaited for further validation of these encouraging early results.
Level of evidence
3b (individual case-controlled study).
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This study was externally funded by Conformis.
Conflicts of interest
All authors of the multicenter study received honoraria for patient enrollment and honoraria as consultants of Conformis which might influence this work.
IRB/Ethics Committee approval was obtained from all participating sites.
All patients signed an informed consent prior to participating in the study.
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Beckmann, J., Steinert, A.F., Huber, B. et al. Customised bi-compartmental knee arthroplasty shows encouraging 3-year results: findings of a prospective, multicenter study. Knee Surg Sports Traumatol Arthrosc 28, 1742–1749 (2020). https://doi.org/10.1007/s00167-019-05595-z
- Bicruciate retaining
- Total knee replacement