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Impact of intra-operative predictive ligament balance on post-operative balance and patient outcome in TKA: a prospective multicenter study

  • Knee Arthroplasty
  • Published:
Archives of Orthopaedic and Trauma Surgery Aims and scope Submit manuscript

Abstract

Introduction

New technologies exist which may assist surgeons to better predict final intra-operative joint balance. Our objectives were to compare the impact of (1) a predictive digital joint tensioning tool on intra-operative joint balance; and (2) joint balance and flexion joint laxity on patient-reported outcomes.

Materials and methods

Two-hundred Eighty patients received posterior cruciate ligament sacrificing TKA with ultra-congruent tibial inserts using a robotic-assisted navigation platform. Patients were divided into those in which a Predictive Plan with a digital joint-tensioning device was used (PP) and those in which it was not (NPP), in all cases final post-operative joint gaps were collected immediately before final implantation. Demographics and KOOS were collected pre-operatively. KOOS, complications and satisfaction were collected at 3, 6 and 12 months post-operatively. Optimal balance difference between PP and NPP was defined and compared using area-under-the-curve analysis (AUC). Outcomes were then compared according to the results from the AUC.

Results

AUC analysis yielded a balance threshold of 1.5 mm, in which the PP group achieved a higher rate of balance throughout flexion compared to the NPP group: extension: 83 vs 52%; Midflexion: 82 vs 55%; Flexion 89 vs 68%; Flexion to Extension 80 vs 49%; p ≤ 0.003. Higher KOOS scores were observed in knees balanced within 1.5 mm across all sub-scores at various time points, however, differences did not exceed the minimum clinically important difference (MCID). Patients with > 1.5 mm flexion laxity medially or laterally had an increased likelihood of 2.2 (1.1–4.4) and 2.5 (1.3–4.8), respectively, for failing to achieve the Patient Acceptable Symptom State for KOOS Pain at 12 months. Patient satisfaction was high in both the PP and NPP groups (97.4 and 94.7%, respectively).

Conclusions

Use of a predictive joint tensioning tool improved the final balance in TKA. Improved outcomes were found in balanced knees; however, this improvement did not achieve the MCID, suggesting further studies may be required to define optimal balance targets. Limiting medial and lateral flexion laxity resulted in an increased likelihood of achieving the Patient Acceptable Symptom State for KOOS Pain.

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Funding

Funding for this study was provided by Corin Group Plc.

Author information

Authors and Affiliations

  1. Connecticut Joint Replacement Institute, Hartford, CT, USA

    John M. Keggi

  2. Corin USA, 480 Paramount Drive, Raynham, MA, 02767, USA

    Edgar A. Wakelin, Sami Shalhoub & Christopher Plaskos

  3. NYU Langone Hospital, Department of Orthopedic Surgery, Long Island, NY, USA

    Jan A. Koenig

  4. Gundersen Health System, Viroqua, WI, USA

    Jeffrey M. Lawrence

  5. Flagstaff Bone and Joint, Flagstaff, AZ, USA

    Amber L. Randall

  6. Oklahoma Sports and Orthopedics Institute, Edmond, OK, USA

    Corey E. Ponder

  7. DeClaire LaMacchia Orthopaedic Institute, Rochester Hills, MI, USA

    Jeffrey H. DeClaire

  8. Hospital for Special Surgery, New York, NY, USA

    Stephen Lyman

  9. Kyushu University School of Medicine, Fukuoka, Japan

    Stephen Lyman

Authors
  1. John M. Keggi
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  2. Edgar A. Wakelin
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  3. Jan A. Koenig
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  4. Jeffrey M. Lawrence
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  5. Amber L. Randall
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  6. Corey E. Ponder
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  7. Jeffrey H. DeClaire
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  8. Sami Shalhoub
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  9. Stephen Lyman
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  10. Christopher Plaskos
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Contributions

EW, SS: paid employees of Corin. CP: paid employee, stock options in Corin. JL: paid consultant and speaker to Corin and Stryker. JK: paid consultant, speaker and research support from Corin. JD: paid consultant, speaker and research support Corin, Smith and Nephew and Zimmer Biomet. Royalties from Zimmer Biomet. AR: paid consultant, speaker and research support to Corin. CEP: paid consultant, speaker, research support and Royalties from Corin. Paid consultant to Styker and Med 7. Share holder of Joint Development LLC. JAK: paid consultant, research support, paid speaker and royalties from Corin. SL: paid consultant from Corin and Cell Source (Tokyo).

Corresponding author

Correspondence to Edgar A. Wakelin.

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Ethical approval

IRB approval for this study was obtained from New England Institutional Review Board, No: 120170260.

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Informed consent was obtained from all participants included in this study.

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Keggi, J.M., Wakelin, E.A., Koenig, J.A. et al. Impact of intra-operative predictive ligament balance on post-operative balance and patient outcome in TKA: a prospective multicenter study. Arch Orthop Trauma Surg 141, 2165–2174 (2021). https://doi.org/10.1007/s00402-021-04043-3

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  • DOI: https://doi.org/10.1007/s00402-021-04043-3

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