18 and older, any sex, with Knee Pain or Chronic 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.
Clinical PerformancePrimary· Pre-op (Baseline), 6 weeks, 3 months, and 1 year
EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.
Preop
Group
Value
95% CI
Robotic Assisted TKA
.540
± .268
Conventional TKA
.442
± .256
6 Week
Group
Value
95% CI
Robotic Assisted TKA
.740
± .166
Conventional TKA
.763
± .179
3 Month
Group
Value
95% CI
Robotic Assisted TKA
.826
± .137
Conventional TKA
.842
± .128
1 Year
Group
Value
95% CI
Robotic Assisted TKA
.889
± .145
Conventional TKA
.891
± .137
OxfordPrimary· Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).
Preop
Group
Value
95% CI
Robotic Assisted TKA
24.6
± 9.2
Conventional TKA
22.2
± 8.2
6 Week
Group
Value
95% CI
Robotic Assisted TKA
32.0
± 7.6
Conventional TKA
32.5
± 6.8
3 Month
Group
Value
95% CI
Robotic Assisted TKA
38.2
± 6.8
Conventional TKA
38.5
± 6.9
1 Year
Group
Value
95% CI
Robotic Assisted TKA
42.4
± 5.4
Conventional TKA
41.2
± 5.8
Post-Operative Pain & SatisfactionPrimary· 6 weeks, 3 months, and 1 year
Post-Operative Pain \& Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.
6 Week
Group
Value
95% CI
Robotic Assisted TKA
80
Conventional TKA
32
Robotic Assisted TKA
32
Conventional TKA
9
Robotic Assisted TKA
12
Conventional TKA
2
Robotic Assisted TKA
0
Conventional TKA
1
3 Month
Group
Value
95% CI
Robotic Assisted TKA
89
Conventional TKA
34
Robotic Assisted TKA
22
Conventional TKA
7
Robotic Assisted TKA
9
Conventional TKA
1
Robotic Assisted TKA
0
Conventional TKA
0
1 Year
Group
Value
95% CI
Robotic Assisted TKA
77
Conventional TKA
23
Robotic Assisted TKA
11
Conventional TKA
8
Robotic Assisted TKA
6
Conventional TKA
3
Robotic Assisted TKA
1
Conventional TKA
0
Total Range of MotionPrimary· Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop
Preop
Group
Value
95% CI
Robotic Assisted TKA
121.0
± 13.9
Conventional TKA
115.7
± 16.2
6 Week
Group
Value
95% CI
Robotic Assisted TKA
114.5
± 12.9
Conventional TKA
111.4
± 11.1
3 Month
Group
Value
95% CI
Robotic Assisted TKA
121.1
± 11.0
Conventional TKA
120.7
± 9.7
1 Year
Group
Value
95% CI
Robotic Assisted TKA
122.7
± 9.5
Conventional TKA
120.4
± 10.8
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Robotic Assisted TKA
Serious: 7/133 (5%)
Deaths: 0/133
Conventional TKA
Serious: 1/48 (2%)
Deaths: 0/48
Serious adverse events (7 terms)
Reaction
System
Robotic Assisted TKA
Conventional TKA
Patellar Periprosthetic Fracture
Musculoskeletal and connective tissue disorders
—
—
Transverse Femur Fracture at site of ROSA pins
Surgical and medical procedures
—
—
Patient seen for 2nd opinion at another orthopaedic provider. Diagnosed with tibial Loosening
Musculoskeletal and connective tissue disorders
—
—
Stiffness/Limited Motion due to missing PT; Patient underwent open lysis of adhesions and poly swap.
Musculoskeletal and connective tissue disorders
—
—
Pneumonia
Respiratory, thoracic and mediastinal disorders
—
—
Anemia and Melena
Blood and lymphatic system disorders
—
—
Calf Pain/Possible DVT
Vascular disorders
—
—
Other adverse events (37 terms — click to expand)
Reaction
System
Robotic Assisted TKA
Conventional TKA
Stiffness/Limited ROM
Musculoskeletal and connective tissue disorders
—
—
Contralateral Knee Replacement
Musculoskeletal and connective tissue disorders
—
—
Inability to eat/full/nausea/vomiting/diarrhea
Gastrointestinal disorders
—
—
Pain
Musculoskeletal and connective tissue disorders
—
—
Erythema
Skin and subcutaneous tissue disorders
—
—
Urinary tract infection/unable to void
Renal and urinary disorders
—
—
Hip/DJD
Musculoskeletal and connective tissue disorders
—
—
Lumbar Stenosis/Degenerative Disc/Facet Disease
Musculoskeletal and connective tissue disorders
—
—
Right Frontal Ischemic Infarct
Nervous system disorders
—
—
Pulmonary Embolism
Vascular disorders
—
—
Periprosthetic Joint Infection
Infections and infestations
—
—
Dermatitis/allergic reaction
Skin and subcutaneous tissue disorders
—
—
Hypotension
Cardiac disorders
—
—
Hypertension
Cardiac disorders
—
—
Leukocytosis
Blood and lymphatic system disorders
—
—
Infection (non-knee)
Infections and infestations
—
—
Cellulitis
Infections and infestations
—
—
Nonunion Femur Fracture
Musculoskeletal and connective tissue disorders
—
—
Plantar Fascitis
Musculoskeletal and connective tissue disorders
—
—
Contralateral Knee Pain
Musculoskeletal and connective tissue disorders
—
—
Neuro not intact to Left foot and ankle unable to Dorsiflex
Nervous system disorders
—
—
Lytic Lesions in Thoracic Spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Amelanotic Melanoma Right Upper Arm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Possible DVT
Vascular disorders
—
—
Nasal Bleeding
Vascular disorders
—
—
Mild Crepitus
Musculoskeletal and connective tissue disorders
—
—
Traumatic Injury/Twisting
Musculoskeletal and connective tissue disorders
—
—
Superficial Infection of Incision
Infections and infestations
—
—
Irritation of the distal aspect of Incision
Infections and infestations
—
—
Severe Swelling of the surgical knee following surgery
Skin and subcutaneous tissue disorders
—
—
Trauma/Fall
Skin and subcutaneous tissue disorders
—
—
Arthritis Increased
Musculoskeletal and connective tissue disorders
—
—
Dizzy/Nausea from medication
Surgical and medical procedures
—
—
Wound Dehiscence Left Ankle
Injury, poisoning and procedural complications
—
—
Stress Reaction at Femoral Pin Sites
Surgical and medical procedures
—
—
Patella Dislocation
Surgical and medical procedures
—
—
Skyline Patella Lateral Tilt and Erosion of Non-Resurfaced Patella
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zimmer Biomet
Last refreshed: 3 May 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/NCT03969654.