Clinical evaluation of the *spacer technique* as a simple PCL-balancing tool for implantation of a PCL-retaining total knee replacement.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

- Patient presenting with non-inflammatory osteoarthritis (radiologically confirmed), requiring total knee replacement
- Patient has an intact PCL and patient has indication for a PCL-retaining Genesis II TKR
- Patient is 40 to 70 years of age, inclusive
- Patient plans to be available for follow up through 2 years postoperative.
- Patient is in a stable health and is free of, or treated for, cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk.

Exclusion Criteria

- Patient is known to have insufficient femoral or tibial bone stock
- Patient has shown to have insufficient posterior cruciate ligament during surgery
- Patient has a BMI > 35
- Patient's expected physical activity after surgery is 2 or less on the UCLA Activity Scale
- Patient has had previous hip or knee replacement surgery in the last 6 months, or is planned to have a (second) hip or knee replacement in the next 6-12 months
- Patient has had major, non-arthroscopic surgery to the study knee, including HTO.
- Patient has an active, local infection or systemic infection
- Patient has physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow up
- Patient has grade 3 collateral ligament insufficiency
- Patient has knee flexion < 90 degrees
- Patient has fixed flexion deformity >10 degrees (passive extension lag)
- Patient has > 30 degrees extension deficit (active restraint to extension)
- Patient has varus or valgus deformity >10 degrees
- Patient has rheumatoid arthritis, any autoimmune disorder or immunosuppressive disorder
- Patient is pregnant or plans to become pregnant during course of study
- Patient has a known sensitivity to materials in the device

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The postoperative medial tibiofemoral contact point of the knee in 90 degrees<br /><br>of flexion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Antero-posterior stability of the knee, clinical and functional outcomes (Knee<br /><br>Society Score (KSS), KOOS, patellofemoral score), active and passive ROM, VAS<br /><br>pain and satisfaction.</p><br>