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

NCT04114201 | Completed

• 1 other identifier: TKA-PSI
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Gonarthrosis

Outcome Measures

Primary Outcomes (1)

• OR time

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

  during surgery

Secondary Outcomes (6)

• OR resource use: number of instrument trays

  during surgery

• OR Setup Time

  during surgery

• Oxford Knee Score

  1 year after surgery

• visual analog scale (VAS)

  1 year after surgery

• device alignment

  1 year after surgery

Study Arms (2)

PSI

EXPERIMENTAL

Patients received TKA using patient-specific Instrumentation.

Procedure: PSI

Conventional

ACTIVE COMPARATOR

Patients received TKA conventional Instrumentation.

Procedure: Conventional

Interventions

PSI PROCEDURE

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

PSI

Conventional PROCEDURE

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

Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Zimmer Biomet: collaborator

Study Sites (3)

Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch

Lorsch, Hesse, 64653, Germany

Location

Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser

Nienburg, Lower Saxony, 31582, Germany

Location

University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were operated consecutively with conventional and patient-specific Instrumentation.

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: August 2, 2012
• Primary Completion: February 23, 2017
• Study Completion: February 23, 2017
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)