Matched Pair Study - Kinematic Vs Mechanical Alignment

Medacta

Status: Completed

Conditions: Joint Disease; Osteoarthritis, Knee

Treatments: Device: GMK Sphere®; Procedure: Mechanical alignment; Procedure: Kinematic alignment

Study type: Observational

Funder types: Industry

Identifiers

NCT03446391

P02.010.18

Details and patient eligibility

About

The aim of this study is to evaluate postoperative knee function after total knee arthroplasty performed according to the anatomical alignment and compare these results to those of a matched historical cohort of patients operated with mechanical alignment.

Full description

The 25 patients, of the Kinematic group, are prospectively enrolled. While, the data of patients of the Mechanical group, are retrospectively collected from an historical collection.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use).
2. Patients necessitating primary Total Knee Replacement
3. Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.

Exclusion criteria

1. Those with one or more medical conditions identified as a contraindication defined by the labeling on Medacta implants used in this study.
2. Previous osteotomy around the knee
3. Ligament instability likely to require higher level of constraint
4. Previous infection or inflammatory disease
5. Extraarticular deformities for which a femoral intramedullary guide rod can't be inserted into the canal and use of Computer Assisted Orthopaedic Surgery (CAOS) or Patient Specific Instrumentation (PSI) is required.

Trial design

50 participants in 2 patient groups

Kinematic alignment with GMK Sphere®

Description:

Patients enrolled prospectively with surgeries planned to get kinematic alignment

Treatment:

Procedure: Kinematic alignment

Device: GMK Sphere®

Mechanical alignment with GMK Sphere®

Description:

Historical group who had mechanical alignment, match-paired with the prospective group

Treatment:

Procedure: Mechanical alignment

Device: GMK Sphere®