Does the Use of Patient Specific Instrumentation Improve Outcomes in Knee Arthroplasty Surgery for Osteoarthritis When Compared to Standard Posterior Referenced Instrumentation?

NAActive, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

March 3, 2014

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2024

Conditions
Primary Osteoarthritis Patients Scheduled for Total Knee Replacement SurgeryOsteoarthritis (OA) of the Knee
Interventions
DEVICE

Patient specific instrumentation (PSI)

Cutting guides that are manufactured using advanced imaging and modelling techniques to create instruments that align more closely with the unique anatomy of each patient. Custom guides were created based on a preoperative MRI protocol (Zimmer Patient Specific Instrumentation for NexGen® Complete Knee Solution, Zimmer Biomet, Warsaw, Indiana, United States in collaboration with Materialise NV, Leuven, Belgium) to optimize the placement of the components without the need for intramedullary alignment.

DEVICE

Conventional instruments

Instruments specific to the implant that are used to guide bone cutting in reference to the intramedullary canal or using an extramedullary jig.

PROCEDURE

Cemented Total Knee Arthroplasty

A cemented TKA (NexGen® Complete Knee Solution, Zimmer Biomet, Warsaw, Indiana, United States) is used in all cases with a cruciate retaining (CR) or posterior stabilized (LPS) prosthesis as determined by the surgeon.

Trial Locations (1)

43180

Sahlgrenska University Hospital, Mölndal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Zimmer Biomet

INDUSTRY

collaborator

Ingabritt och Arne Lundbergs Forskningsstiftelse

UNKNOWN

lead

Vastra Gotaland Region

OTHER_GOV