Flexion Deformity, Knee, Fracture of Distal End of Femur, Fracture of Upper End of Tibia, Osteoarthritis, Knee, Post-Traumatic Osteoarthritis of Knee, Rheumatoid Arthritis, Valgus Deformity, Not Elsewhere Classified, Knee, Varus Deformity, Not Elsewhere Classified, Knee
Conditions
Brief summary
A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.
Interventions
DEVICEUnity Knee™ TKR using measured resection
Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
DEVICEUnity Knee™ TKR using ligament balancing
Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique
Sponsors
Corin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects suitable for the Unity Knee™ Total Knee System according to the product Instructions for use * Over 18 years old * Male and female subjects who are skeletally mature * Subjects who have a smartphone (iOS or Android) with internet connection via mobile Internet data or Wi-Fi connection * Subjects able to understand what is expected of them and be able to comply with the study protocol requirements
Exclusion criteria
* Any subject listed for a revision total knee replacement or conversion of a unicondylar replacement to a total knee replacement on the operative knee * Any subject with fixed flexion contracture greater than 20 degrees * Any subject with varus/valgus deformity greater than 15 degrees * Any subject with confirmed osteoarthritis or other pathologies affecting the contralateral knee that is anticipated to require surgery within 12 months * Any subjects with contralateral knee replacement that is anticipated to require revision surgery within 12 months * Any subject whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems * Any subject with a known sensitivity to device material * Any subject who is pregnant * Any subject currently a prisoner * Any subject known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes * Any subject currently involved in any personal injury litigation, medical-legal or worker's compensations claims * Any subject unable to read and understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posterior condylar offset (PCO) | 6 weeks post-op | Any difference in PCO from preoperative to 6 weeks post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Joint line in flexion | 6 weeks post-op | Any difference in medial joint line position measured using the PCO |
| Femoral flexion angle | 6 weeks post-op | — |
| Distal femoral component angle | 6 weeks post-op | — |
| Tibial component angle | 6 weeks post-op | — |
| Tibial slope | 6 weeks post-op | — |
| Joint line in extension | 6 weeks post-op | Any difference in vertical distance from medial epicondyle to distal medial femoral condyle articular surface from preoperative to 6 weeks post-surgery |
| Oxford Knee Score (OKS) | Up to 24 months post-op | — |
| Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS) | Up to 24 months post-op | — |
| EuroQoL 5-dimension health state (EQ-5D 5-level) | Up to 6 months post-op | — |
| Hospital Anxiety and Depression Scale (HADS) | Up to 6 months post-op | — |
| Hip-knee-ankle (HKA) angle | 6 weeks post-op | — |
Outcome results
None listed