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

Primary Purpose

Gonarthrosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PSI
Conventional
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gonarthrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch
  • Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser
  • University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PSI

Conventional

Arm Description

Patients received TKA using patient-specific Instrumentation.

Patients received TKA conventional Instrumentation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

OR resource use: number of instrument trays
OR Efficiency measured by number of instrument trays used
OR Setup Time
Operating Room (OR) Setup Time in minutes
Oxford Knee Score
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.
visual analog scale (VAS)
patient-reported pain scores as measured by the visual analog scale (VAS), ranging from 0 (worst) to 10 (best).
device alignment
device alignment as determined using radiographs (A/P long-standing and lateral films)
EQ-5D-3L
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

Full Information

First Posted
October 1, 2019
Last Updated
October 2, 2019
Sponsor
Technische Universität Dresden
Collaborators
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT04114201
Brief Title
Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation
Acronym
TKA PSI
Official Title
Evaluation of Zimmer® Patient Specific Instrumentation vs. Conventional Instrumentation in Total Knee Arthroplasty Procedures: Clinical and Economic Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2, 2012 (Actual)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were operated consecutively with conventional and patient-specific Instrumentation.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSI
Arm Type
Experimental
Arm Description
Patients received TKA using patient-specific Instrumentation.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Patients received TKA conventional Instrumentation.
Intervention Type
Procedure
Intervention Name(s)
PSI
Intervention Description
Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
Intervention Type
Procedure
Intervention Name(s)
Conventional
Intervention Description
Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
Primary Outcome Measure Information:
Title
OR time
Description
Operating Room (OR) time: incision to Close in minutes
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
OR resource use: number of instrument trays
Description
OR Efficiency measured by number of instrument trays used
Time Frame
during surgery
Title
OR Setup Time
Description
Operating Room (OR) Setup Time in minutes
Time Frame
during surgery
Title
Oxford Knee Score
Description
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.
Time Frame
1 year after surgery
Title
visual analog scale (VAS)
Description
patient-reported pain scores as measured by the visual analog scale (VAS), ranging from 0 (worst) to 10 (best).
Time Frame
1 year after surgery
Title
device alignment
Description
device alignment as determined using radiographs (A/P long-standing and lateral films)
Time Frame
1 year after surgery
Title
EQ-5D-3L
Description
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
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch
City
Lorsch
State/Province
Hesse
ZIP/Postal Code
64653
Country
Germany
Facility Name
Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser
City
Nienburg
State/Province
Lower Saxony
ZIP/Postal Code
31582
Country
Germany
Facility Name
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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