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

Gonarthrosis Clinical Trial

— TKA PSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114201
• Other study ID #: TKA-PSI
• Status: Completed
• Phase: N/A
• Start date: August 2, 2012
• Est. completion date: February 23, 2017

Study information

• Verified date: October 2019
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis, Knee

Intervention

Procedure:
• PSI
Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
• Conventional
Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).

Locations

Country	Name	City	State
Germany	University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden	Dresden	Saxony
Germany	Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch	Lorsch	Hesse
Germany	Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser	Nienburg	Lower Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Zimmer Biomet

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OR time	Operating Room (OR) time: incision to Close in minutes	during surgery
Secondary	OR resource use: number of instrument trays	OR Efficiency measured by number of instrument trays used	during surgery
Secondary	OR Setup Time	Operating Room (OR) Setup Time in minutes	during surgery
Secondary	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.	1 year after surgery
Secondary	visual analog scale (VAS)	patient-reported pain scores as measured by the visual analog scale (VAS), ranging from 0 (worst) to 10 (best).	1 year after surgery
Secondary	device alignment	device alignment as determined using radiographs (A/P long-standing and lateral films)	1 year after surgery
Secondary	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	1 year after surgery