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

Technische Universität Dresden

Status: Completed

Conditions: Gonarthrosis

Treatments: Procedure: Conventional; Procedure: PSI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04114201

TKA-PSI

Details and patient eligibility

About

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

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

PSI

Experimental group

Description:

Patients received TKA using patient-specific Instrumentation.

Treatment:

Procedure: PSI

Conventional

Active Comparator group

Description:

Patients received TKA conventional Instrumentation.

Treatment:

Procedure: Conventional