A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03511144
• Other study ID #: CSP2015-04
• Status: Withdrawn
• Phase: N/A
• Start date: July 2018
• Est. completion date: July 2020

Study information

• Verified date: November 2018
• Source: Corin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Congenital Abnormalities
• Flexion Deformity, Knee
• Fracture of Distal End of Femur
• Fracture of Upper End of Tibia
• Fractures, Bone
• Osteoarthritis
• Osteoarthritis, Knee
• Post-Traumatic Osteoarthritis of Knee
• Rheumatoid Arthritis
• Valgus Deformity, Not Elsewhere Classified, Knee
• Varus Deformity, Not Elsewhere Classified, Knee

Intervention

Device:
• Unity Knee™ TKR using measured resection
Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
• Unity Knee™ TKR using ligament balancing
Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posterior condylar offset (PCO)	Any difference in PCO from preoperative to 6 weeks post-surgery	6 weeks post-op
Secondary	Joint line in extension	Any difference in vertical distance from medial epicondyle to distal medial femoral condyle articular surface from preoperative to 6 weeks post-surgery	6 weeks post-op
Secondary	Joint line in flexion	Any difference in medial joint line position measured using the PCO	6 weeks post-op
Secondary	Femoral flexion angle		6 weeks post-op
Secondary	Distal femoral component angle		6 weeks post-op
Secondary	Tibial component angle		6 weeks post-op
Secondary	Tibial slope		6 weeks post-op
Secondary	Hip-knee-ankle (HKA) angle		6 weeks post-op
Secondary	Oxford Knee Score (OKS)		Up to 24 months post-op
Secondary	Knee injury and Osteoarthritis Score - Physical Function Shortform (KOOS-PS)		Up to 24 months post-op
Secondary	EuroQoL 5-dimension health state (EQ-5D 5-level)		Up to 6 months post-op
Secondary	Hospital Anxiety and Depression Scale (HADS)		Up to 6 months post-op