Under 80, any sex, with Total Knee Arthroplasty or Arthroplasty of Knee. 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.
Count of Participants With Post-operative Mechanical AlignmentPrimary· 1 month
The number of participants achieving post-operative mechanical alignment within ±3 degrees from target with "Yes" indicating mechanical alignment was achieved and "No" indicating mechanical alignment was not achieved.
Group
Value
95% CI
Study Population
106
Study Population
9
Count of Participants With Implant SurvivalSecondary· 2 years
Number of participants with implant survivorship where "No" indicates a revision surgery was not required and "Yes" indicates a revision surgery was required by the 2 year postoperative visit.
Group
Value
95% CI
Study Population
117
Study Population
5
Knee Society Score 2011Secondary· Baseline, 1 month, 6 months, 1 year, and 2 years
The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in Total Knee Arthroplasty (TKA) participants. The 2011 Knee Society Score consists of 4 separate subscales with a higher number indicating a better outcome:
* A Patient Expectation Score (5items: 15 points, range 0-15)
* A Functional Activity Score (19 items: 100 points, range 0-100)
* An "Objective" Knee Score (7 items: 100 points, range 0-100)
* A Patient Satisfaction Score (5 items: 40 points, range 0-40)
Patient Expectation: Baseline
Group
Value
95% CI
Study Population
14.21
± 1.627
Patient Expectation: 1 Month
Group
Value
95% CI
Study Population
8.42
± 2.819
Patient Expectation: 6 Months
Group
Value
95% CI
Study Population
9.78
± 3.391
Patient Expectation: 1 Year
Group
Value
95% CI
Study Population
9.39
± 3.040
Patient Expectation: 2 Years
Group
Value
95% CI
Study Population
9.97
± 2.485
Functional Activity: Baseline
Group
Value
95% CI
Study Population
42.13
± 15.914
Functional Activity: 1 Month
Group
Value
95% CI
Study Population
46.55
± 16.155
Functional Activity: 6 Months
Group
Value
95% CI
Study Population
72.28
± 15.819
Quality of Life EQ-5D-5LSecondary· Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) was graded on a scale of 0 to 100, with 100 being the best health you can imagine and 0 indicating the worst.
Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
Baseline
Group
Value
95% CI
Study Population
11.84
± 12.084
1 Month
Group
Value
95% CI
Study Population
17.31
± 19.603
6 Months
Group
Value
95% CI
Study Population
51.45
± 25.377
1 Year
Group
Value
95% CI
Study Population
66.31
± 26.598
2 Years
Group
Value
95% CI
Study Population
78.56
± 26.095
Hospital Length of StaySecondary· During hospitalization, up to 6 days
Hospital length of stay measured in days
Group
Value
95% CI
Study Population
2.04
± 0.837
Operative TimeSecondary· During surgery, up to 235 minutes
Operative time taken for the surgery measured in minutes.
Group
Value
95% CI
Study Population
90.48
± 29.316
Radiographic Assessment - Anteroposterior (AP) AngleSecondary· Baseline, 1 month, 6 months, 1 year, and 2 years
AP Angle mechanical alignment of femoral flexion, tibial angle, and total valgus angle
Femoral Flexion: Baseline
Group
Value
95% CI
Study Population
65.39
± 40.711
Femoral Flexion: 1 Month
Group
Value
95% CI
Study Population
71.77
± 37.265
Femoral Flexion: 6 Months
Group
Value
95% CI
Study Population
70.10
± 38.357
Femoral Flexion: 1 Year
Group
Value
95% CI
Study Population
73.41
± 35.754
Femoral Flexion: 2 Years
Group
Value
95% CI
Study Population
72.89
± 36.198
Tibial Angle: Baseline
Group
Value
95% CI
Study Population
62.34
± 38.578
Tibial Angle: 1 Month
Group
Value
95% CI
Study Population
69.07
± 37.639
Tibial Angle: 6 Months
Group
Value
95% CI
Study Population
66.59
± 38.915
Radiographic Assessment - Lateral AngleSecondary· Baseline, 1 month, 6 months, 1 year, and 2 years
Lateral Angle mechanical alignment of femoral flexion and tibial angle.
Lateral Angle Femoral Flexion: Baseline
Group
Value
95% CI
Study Population
6.12
± 2.233
Lateral Angle Femoral Flexion: 1 Month
Group
Value
95% CI
Study Population
2.68
± 2.600
Lateral Angle Femoral Flexion: 6 Months
Group
Value
95% CI
Study Population
2.41
± 2.499
Lateral Angle Femoral Flexion: 1 Year
Group
Value
95% CI
Study Population
3.10
± 9.465
Lateral Angle Femoral Flexion: 2 Years
Group
Value
95% CI
Study Population
3.31
± 9.763
Tibial Angle: Baseline
Group
Value
95% CI
Study Population
80.18
± 19.654
Tibial Angle: 1 Month
Group
Value
95% CI
Study Population
66.30
± 37.277
Tibial Angle: 6 Months
Group
Value
95% CI
Study Population
63.79
± 38.965
Radiographic Assessment - Count of Participant DisplacementsSecondary· 6 months
Number of participants with either no displacement or displacement observed at the 6-month follow-up visit.
Degree of displacement measured in millimeters (mm) for participants with displacement observed at the 6-month follow-up visit.
Group
Value
95% CI
Study Population
3.95
± 2.663
Adverse events — posted to ClinicalTrials.gov
Time frame: Time of surgery (i.e., device implantation) through end of the study (2 year post-operative follow-up)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Study Population
Serious: 26/122 (21%)
Deaths: 2/122
Serious adverse events (26 terms)
Reaction
System
Study Population
Recurrent dislocation, right hip
Musculoskeletal and connective tissue disorders
—
Quadricep tendon rupture
Musculoskeletal and connective tissue disorders
—
Delayed wound healing
Blood and lymphatic system disorders
—
Arthrofibrosis of total knee arthroplasty
Musculoskeletal and connective tissue disorders
—
Arthrofibrosis right knee
Musculoskeletal and connective tissue disorders
—
Instability of internal left knee prosthesis, init. encounter
Musculoskeletal and connective tissue disorders
—
Patellar tendon tear right knee
Musculoskeletal and connective tissue disorders
—
Prostate cancer (reoccurence)
Reproductive system and breast disorders
—
Deceased, unknown cause
Investigations
—
Rt knee effusion
Musculoskeletal and connective tissue disorders
—
Ischemic stroke in left MCA region
Cardiac disorders
—
GI bleed
Gastrointestinal disorders
—
Pulmonary atelectasis J98.11
Skin and subcutaneous tissue disorders
—
Right ankle fracture
Respiratory, thoracic and mediastinal disorders
—
Periprosthetic infection
Blood and lymphatic system disorders
—
Macular Pucker with surgical repair
Eye disorders
—
Cataracts
Eye disorders
—
Right knee pain, lumbar sprain / strain
Musculoskeletal and connective tissue disorders
—
Pain in left knee
Musculoskeletal and connective tissue disorders
—
Fall causing torn tendon
Musculoskeletal and connective tissue disorders
—
Infection right knee
Blood and lymphatic system disorders
—
Acquired instability, left knee
Musculoskeletal and connective tissue disorders
—
Arthrofibrosis (R) knee
Musculoskeletal and connective tissue disorders
—
Left stiffness of knee with history of replacement
The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments. An additional study purpose is to document clinical and patient-reported outcomes in subjects receiving TKA with the Navio ™ system.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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: 8 October 2024
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/NCT03317834.