Clinical trial NCT03511144: A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System
Official title: A Prospective Randomised Double Blind Single Centre Study Comparing Measured Resection and Ligament Balancing Implantation Techniques Using the Unity Knee™ Total Knee System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis, Knee
Rheumatoid Arthritis
Post-Traumatic Osteoarthritis of Knee
Varus Deformity, Not Elsewhere Classified, Knee
Valgus Deformity, Not Elsewhere Classified, Knee
Flexion Deformity, Knee
Fracture of Distal End of Femur
Fracture of Upper End of Tibia
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.


Eligibility criteria: 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

Primary outcomes:
measure: Posterior condylar offset (PCO)
timeFrame: 6 weeks post-op
Secondary outcomes:
measure: Joint line in extension
timeFrame: 6 weeks post-op
measure: Joint line in flexion
timeFrame: 6 weeks post-op
measure: Femoral flexion angle
timeFrame: 6 weeks post-op
measure: Distal femoral component angle
timeFrame: 6 weeks post-op
measure: Tibial component angle
timeFrame: 6 weeks post-op
measure: Tibial slope
timeFrame: 6 weeks post-op
measure: Hip-knee-ankle (HKA) angle
timeFrame: 6 weeks post-op
measure: Oxford Knee Score (OKS)
timeFrame: Up to 24 months post-op
measure: Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS)
timeFrame: Up to 24 months post-op
measure: EuroQoL 5-dimension health state (EQ-5D 5-level)
timeFrame: Up to 6 months post-op
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Up to 6 months post-op
Other outcomes:
Locations:
Study officials:
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