18 and older, any sex, with Non-inflammatory Degenerative Joint Disease or Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Post-operative Leg AlignmentPrimary· 6 weeks
The number of participants with knees achieving post-operative leg alignment was taken by radiographic assessment at 6 weeks. Post-operative leg alignment was achieved when the deviation from the participant specific target did not exceed ±3 degrees.
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the femoral flexion angle in degrees was obtained using standard radiographic tools. Femoral flexion angle is defined as the angle formed between a line across the base of the femoral condyles and a line that is centered along the femoral canal.
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. From the A/P radiograph, the tibial angle denotes the angle formed on the medial side of the knee from intersecting lines parallel to the tibial base plate and a line drawn parallel to the tibial canal.
Group
Value
95% CI
CORI UKA
84
± NA
Conventional UKA
89
± 5.66
Component Alignment: Total Antero-Posterior (A/P) Valgus AngleSecondary· 6 weeks
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The total valgus angle is the sum of the femoral flexion angle and the tibial angle.
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view femoral flexion angle in degrees was obtained from the intersection of a line from the center of the femoral implant to the top of the femur with a line through the femoral canal. The angle is measured on the proximal side of the intersection.
Component alignment assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery. The lateral view tibial angle in degrees was obtained from the intersection of a line drawn parallel to the bottom of the tibial base insert and a line through the center of the tibial base and the tibial canal.
Group
Value
95% CI
CORI UKA
86
± NA
Conventional UKA
85.5
± 0.71
Radiographic AssessmentSecondary· 12 months
Radiographic assessment measured by number of participants with any radiographic finds on antero-posterior (A/P) and lateral (L) views (yes/no). Radiographic findings indicated the presence of radiolucent lines, osteolysis \& implant migration.
Group
Value
95% CI
CORI UKA
1
Conventional UKA
1
CORI UKA
0
Conventional UKA
0
2011 Knee Society Score (KSS): Objective Knee ScoreSecondary· Baseline, 6 weeks, 6 months, and 12 months
The 2011 Knee Society Score consists of 4 separate sub-scales. The "Objective" Knee Score is seven items with a range of 0 to 100, with a higher score indicating a better outcome.
Baseline
Group
Value
95% CI
CORI UKA
49
± 32.53
Conventional UKA
33.5
± 3.54
6 weeks
Group
Value
95% CI
CORI UKA
62.5
± 4.95
Conventional UKA
57
± 7.07
6 months
Group
Value
95% CI
CORI UKA
61.5
± 4.95
Conventional UKA
50.5
± 17.68
12 months
Group
Value
95% CI
CORI UKA
70
± NA
Conventional UKA
49
± NA
2011 Knee Society Score (KSS): Satisfaction Knee ScoreSecondary· Baseline, 6 weeks, 6 months, and 12 months
The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Satisfaction Score is five items with a range of 0 to 40, with a higher score indicating a better outcome.
Baseline
Group
Value
95% CI
CORI UKA
19
± 1.41
Conventional UKA
10
± 2.83
6 weeks
Group
Value
95% CI
CORI UKA
24
± 0
Conventional UKA
23
± 4.24
6 months
Group
Value
95% CI
CORI UKA
28
± 2.83
Conventional UKA
26
± 2.83
12 months
Group
Value
95% CI
CORI UKA
34
± NA
Conventional UKA
30
± NA
2011 Knee Society Score (KSS): Expectation ScoreSecondary· Baseline, 6 weeks, 6 months, and 12 months
The 2011 Knee Society Score consists of 4 separate sub-scales. The Patient Expectation Score is three items with a range of 0 to 15, with a higher score indicating a better outcome. The Expectation score indicates the patient's opinion on the extent they expect the operation to improve their knee pain, and ability to perform activities of daily living and recreational activities.
Baseline
Group
Value
95% CI
CORI UKA
13
± 1.41
Conventional UKA
11
± 1.41
6 weeks
Group
Value
95% CI
CORI UKA
9.5
± 3.54
Conventional UKA
8.5
± 3.54
6 months
Group
Value
95% CI
CORI UKA
11
± 5.66
Conventional UKA
10
± 1.41
12 months
Group
Value
95% CI
CORI UKA
8
± NA
Conventional UKA
9
± NA
2011 Knee Society Score (KSS): Functional ScoreSecondary· Baseline, 6 weeks, 6 months, and 12 months
The 2011 Knee Society Score consists of 4 separate sub-scales. The Functional Score is nineteen items with a range of 0 to 100, with a higher score indicating a better outcome. Functional Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities.
The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to assess perceived function and pain answered on a Likert scale. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Baseline
Group
Value
95% CI
CORI UKA
22.5
± 0.71
Conventional UKA
18.5
± 3.54
6 weeks
Group
Value
95% CI
CORI UKA
16
± 2.83
Conventional UKA
29.5
± 2.12
6 months
Group
Value
95% CI
CORI UKA
35.5
± 0.71
Conventional UKA
35
± 8.49
12 months
Group
Value
95% CI
CORI UKA
38
± NA
Conventional UKA
41
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from procedure to study termination, approximately 12 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CORI UKA
Serious: 1/2 (50%)
Deaths: 0/2
Conventional UKA
Serious: 1/2 (50%)
Deaths: 0/2
Serious adverse events (3 terms)
Reaction
System
CORI UKA
Conventional UKA
BROKEN ANKLE
Musculoskeletal and connective tissue disorders
—
—
INCREASED PAIN AND SWELLING IN RIGHT LEG
Musculoskeletal and connective tissue disorders
—
—
BILATERAL PULMONARY EMBOLISM (PE) & DEEP VEIN THROMBOSIS (DVT)
Respiratory, thoracic and mediastinal disorders
—
—
Other adverse events (4 terms — click to expand)
Reaction
System
CORI UKA
Conventional UKA
RIGHT SHOULDER PAIN
Musculoskeletal and connective tissue disorders
—
—
PAIN IN KNEE, PREPATELLAR SWELLING
Musculoskeletal and connective tissue disorders
—
—
BURNING AND ALTERED SENSATION AROUND LATERAL ASPECT OF SURGICAL WOUND.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew, Inc.
Last refreshed: 25 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04797897.