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No Benefit of Patient-specific Instrumentation in TKA on Functional and Gait Outcomes: A Randomized Clinical Trial

  • Clinical Research
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Clinical Orthopaedics and Related Research®

Abstract

Background

Although some clinical reports suggest patient-specific instrumentation in TKA may improve alignment, reduce surgical time, and lower hospital costs, it is unknown whether it improves pain- and function-related outcomes and gait.

Questions/purposes

We hypothesized that TKA performed with patient-specific instrumentation would improve patient-reported outcomes measured by validated scoring tools and level gait as ascertained with three-dimensional (3-D) analysis compared with conventional instrumentation 3 months after surgery.

Methods

We randomized 40 patients into two groups using either patient-specific instrumentation or conventional instrumentation. Patients were evaluated preoperatively and 3 months after surgery. Assessment tools included subjective functional outcome and quality-of-life (QOL) scores using validated questionnaires (New Knee Society Score© [KSS], Knee Injury and Osteoarthritis Outcome Score [KOOS], and SF-12). In addition, gait analysis was evaluated with a 3-D system during level walking. The study was powered a priori at 90% to detect a difference in walking speed of 0.1 m/second, which was considered a clinically important difference, and in a post hoc analysis at 80% to detect a difference of 10 points in KSS.

Results

There were improvements from preoperatively to 3 months postoperatively in functional scores, QOL, and knee kinematic and kinetic gait parameters during level walking. However, there was no difference between the patient-specific instrumentation and conventional instrumentation groups in KSS, KOOS, SF-12, or 3-D gait parameters.

Conclusions

Our observations suggest that patient-specific instrumentation does not confer a substantial advantage in early functional or gait outcomes after TKA. It is possible that differences may emerge, and this study does not allow one to predict any additional variances in the intermediate followup period from 6 months to 1 year postoperatively. However, the goals of the study were to investigate the recovery period as early pain and functional outcomes are becoming increasingly important to patients and surgeons.

Level of Evidence

Level I, therapeutic study. See the Instructions to Authors for a complete description of levels of evidence.

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Acknowledgments

We acknowledge Damien Girard MD (Department of Orthopedic Surgery, Institute for Locomotion, Aix-Marseille University, Marseille), Guillaume Gauthier MS (Center of Motion and Gait Analysis, Department of Pediatric Orthopedic Surgery, Tim one Hospital, Marseille), and Elisabeth Castanet MS (Center of Motion and Gait Analysis, Department of Pediatric Orthopedic Surgery, Tim one Hospital, Marseille), for their assistance.

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Authors and Affiliations

  1. Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA

    Matthew P. Abdel MD

  2. Department of Orthopedic Surgery, Institute for Locomotion, Aix-Marseille University, 270 Boulevard Sainte Marguerite, BP 29, 13274, Marseille, France

    Sébastien Parratte MD, PhD, Guillaume Blanc MD, Matthieu Ollivier MD & Jean-Noël A. Argenson MD, PhD

  3. Center of Motion and Gait Analysis, Department of Pediatric Orthopaedic Surgery, Timone Hospital, Marseille, France

    Sébastien Parratte MD, PhD, Vincent Pomero PhD, Elke Viehweger MD, PhD, MHA & Jean-Noël A. Argenson MD, PhD

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  1. Matthew P. Abdel MD
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  2. Sébastien Parratte MD, PhD
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  3. Guillaume Blanc MD
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  4. Matthieu Ollivier MD
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Corresponding author

Correspondence to Sébastien Parratte MD, PhD.

Additional information

The institution of one or more of the authors (MPA) has received funding from Biomet (Warsaw, IN, USA), DePuy (Warsaw, IN, USA), Stryker (Mahwah, NJ, USA), and Zimmer (Warsaw, IN, USA). One author certifies that he (J-NAA), or a member of his immediate family has received between USD 100,000 and USD 1,000,000 from Zimmer Inc (royalties and consultant). One author certifies that he (SP), or a member of his immediate family, has received between USD 100,000 and USD 1,000,000 from Zimmer Inc (development of educational programs).

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request.

Each author certifies that his or her institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.

Clinical Orthopaedics and Related Research neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA- approval status, of any drug or device prior to clinical use.

This work was performed at Aix-Marseille University, Marseille, France.

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Abdel, M.P., Parratte, S., Blanc, G. et al. No Benefit of Patient-specific Instrumentation in TKA on Functional and Gait Outcomes: A Randomized Clinical Trial. Clin Orthop Relat Res 472, 2468–2476 (2014). https://doi.org/10.1007/s11999-014-3544-7

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