Clinical trial NCT02145455: Unity Total Knee Replacement Using Two Different Surgical Techniques
Official title: Unity Total Knee Replacement: Prospective Single-centre Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis of the Knee
Keywords: Arthroplasty, Replacement, Knee/methods
Knee Joint/physiopathology
Knee Joint/radiography
Knee Joint/surgery
Knee Prosthesis
Outcome Assessment (Health Care)
Female
Male
Adult
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 111
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: This study will compare two different surgical methods used in total knee replacement with the Unity Total Knee Replacement System. The study will evaluate these two methods based on patients' ability to perform various tasks prior to surgery and at 4 time points during the first 12 months after surgery.

Detailed description: This study will be conducted at a single centre. The study has two treatment groups. One group of 50 knees (approximately 50 subjects) will have a surgical method that uses mechanical alignment (alignment based on how the leg and knee joint move) to determine the proper position of the knee replacement device. The other group of 50 knees (approximately 50 subjects) will have a surgical method that uses anatomical alignment (alignment based on how the anatomy/structure of the leg and knee joint) determine the proper position of the knee replacement device. Subjects will be randomly assigned to one of the two groups. Clinical and functional tests will be conducted pre-operatively and at 6 weeks, 3 months, 6 months and 12 months to determine overall knee function. In addition, a CT scan will be completed pre-operatively and at 6 weeks to assess changes in alignment.

Eligibility criteria: Inclusion Criteria:

* The patient must be listed for a primary total knee replacement using the Corin Unity Total Knee Replacement System, according to the product 'Instructions For Use'
* The patient must give signed informed consent to participate in the study
* The patient must be able to understand all that is expected of them and be able to comply with the study protocol
* Male and female patients who are skeletally mature

Exclusion Criteria:

* Any patient with a total knee replacement not implanted with a Corin Unity Total Knee Replacement
* Any patient with a revision total knee replacement or conversion of a Unicondylar replacement to a total knee replacement on the operative knee
* Any patient with fixed flexion contracture greater than 20 degrees
* Any patient with varus/valgus deformity greater than 15 degrees
* Any case not described in the inclusion criteria
* Any patient who cannot or will not provide signed informed consent for participation in the study
* Any patient whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
* Any patient with a known sensitivity to device material
* Any patient who is pregnant
* Any patient currently a prisoner
* Any patient known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
* Any patient currently involved in any personal injury litigation, medical-legal or worker's compensations claims
* Any patient unable to read and understand English

Primary outcomes:
measure: Power of knee extension
timeFrame: 12 months post-operative
Secondary outcomes:
measure: Timed up and go test
timeFrame: 12 months post-operative
measure: Single leg stance (SLS) test
timeFrame: 12 months post-operative
measure: 6 minute walk test
timeFrame: 12 months post-operative
measure: Timed stairs test
timeFrame: 12 months post-operative
measure: Wii Fit balance test
timeFrame: 12 months post-operative
measure: Ability to kneel
timeFrame: 12 months post-operative
measure: Sloped treadmill test
timeFrame: 12 months post-operative
measure: Walking on uneven ground
timeFrame: 12 months post-operative
measure: CT evaluation
timeFrame: 6 weeks post-operative
measure: Power of knee flexion
timeFrame: 12 months post-operative
measure: Oxford Knee Score (OKS)
timeFrame: 12 months Post-operative
measure: Knee Injury and Osteoarthritis Score (KOOS)
timeFrame: 12 months Post-operative
measure: EuroQoL 5-dimension Health State (EQ-5D)
timeFrame: 12 months Post-operative
measure: Patient Satisfaction Score
timeFrame: 12 months Post-operative
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Exeter Knee Reconstruction Unit at the Princess Elizabeth Orthopaedic Centre
state: Devon
Study officials:
affiliation: Princess Elizabeth Orthopaedic Centre
name: Andrew Toms, MD
role: PRINCIPAL_INVESTIGATOR
References: