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Completed

NCT Number: NCT04114201

Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation

Compare OR resource use and clinical Outcome after Total Knee Arthroplasty using Patient-specific or conventional Instrumentation.

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Key information

Conditions

Gonarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch, Lorsch, Hesse, Germany

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About this study

The aim of this study was to compare OR resource use and clinical Outcome after Total Knee Arthroplasty (TKA) using Patient-specific (PSI) or conventional Instrumentation.

For this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed. Cost per QALY (quality-adjusted life year) was assessed using the German DRG reimbursement and the EQ-5D.

A total of 139 TKA with PSI or conventional instrumentation were included in three Centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Painful, disabled knee joint resulting from osteoarthritis requiring primary TKA
  • Informed Consent: Patient has signed a "Patient Informed Consent.
  • Able and willing to undergo a preoperative MRI scan (for PSI cases) and full-leg, standing radiographs (all cases)
  • Able and willing to follow instructions and complete follow-up
  • Patient receiving Zimmer NexGen Solutions CR-Flex (including Gender Solutions)

Exclusion criteria

  • Patient is skeletally immature
  • Active Infection (including septic knee, distant infection, or osteomyelitis)
  • Severe hip arthrosis
  • Neurological disorders (including, but not limited to Parkinson's disease)
  • Prior unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
  • Hip or knee ankylosis
  • Either rheumatoid or post-traumatic knee arthritis
  • Scheduled for simultaneous bilateral TKA
  • Indications of intra- and/or extra-articular deformations that would inhibit the use of PSI guides
  • Any metal within 150 mm of the joint line for the operative-side knee
  • Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
  • An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
  • A female who is pregnant or lactating
  • Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
  • Arterial disease or stents that would exclude the use of a tourniquet

Treatment and study plan

PSI

Procedure

Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).

Conventional

Procedure

Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).

Primary outcomes

  1. OR time

    Time frame: during surgery

    Operating Room (OR) time: incision to Close in minutes

Secondary outcomes

  1. OR resource use: number of instrument trays

    Time frame: during surgery

    OR Efficiency measured by number of instrument trays used

  2. OR Setup Time

    Time frame: during surgery

    Operating Room (OR) Setup Time in minutes

  3. Oxford Knee Score

    Time frame: 1 year after surgery

    clinical outcome measured by the Oxford Knee Scoring System. The Oxford Knee Score is aggregated to a single score where 0 is the worst and 48 is the best Outcome.

  4. visual analog scale (VAS)

    Time frame: 1 year after surgery

    patient-reported pain scores as measured by the visual analog scale (VAS), ranging from 0 (worst) to 10 (best).

  5. device alignment

    Time frame: 1 year after surgery

    device alignment as determined using radiographs (A/P long-standing and lateral films)

  6. EQ-5D-3L

    Time frame: 1 year after surgery

    patients' health-related Quality of life is measured by the EQ-5D-3L, which aggregates to a single index where 0 is the worst and 1 is the best outcome

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

Evaluation of Zimmer® Patient Specific Instrumentation vs. Conventional Instrumentation in Total Knee Arthroplasty Procedures: Clinical and Economic Outcomes

Acronym: TKA PSI

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2019
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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