Clinical trial NCT04114201: Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation
Official title: Evaluation of Zimmer® Patient Specific Instrumentation vs. Conventional Instrumentation in Total Knee Arthroplasty Procedures: Clinical and Economic Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gonarthrosis
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2019-10-03
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were operated consecutively with conventional and patient-specific Instrumentation.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: OR time
timeFrame: during surgery
Secondary outcomes:
measure: OR resource use: number of instrument trays
timeFrame: during surgery
measure: OR Setup Time
timeFrame: during surgery
measure: Oxford Knee Score
timeFrame: 1 year after surgery
measure: visual analog scale (VAS)
timeFrame: 1 year after surgery
measure: device alignment
timeFrame: 1 year after surgery
measure: EQ-5D-3L
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Lorsch
country: Germany
facility: Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch
state: Hesse
city: Nienburg
country: Germany
facility: Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser
state: Lower Saxony
city: Dresden
country: Germany
facility: University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
state: Saxony
Study officials:
References: