Adults 18 to 75, any sex, with Degenerative Joint Disease. 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.
Implant SurvivorshipPrimary· up to 10 years post-operatively
Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.
Group
Value
95% CI
R3™ Acetabular System
0.89
0.865 – 0.923
Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)Secondary· Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
HOOS is a measurement of function and outcomes of daily living that ranges from 0 to 100 where 0 indicated extreme symptoms (i.e., worse outcome) and 100 indicated no symptoms (i.e., better outcome).
Pre-operative
Group
Value
95% CI
R3™ Acetabular System
37.8
± 16.16
3 Months
Group
Value
95% CI
R3™ Acetabular System
83.2
± 12.39
1 Year
Group
Value
95% CI
R3™ Acetabular System
88.1
± 12.48
3 Years
Group
Value
95% CI
R3™ Acetabular System
87.9
± 12.22
5 Years
Group
Value
95% CI
R3™ Acetabular System
88.0
± 13.76
7 Years
Group
Value
95% CI
R3™ Acetabular System
87.5
± 12.43
10 Years
Group
Value
95% CI
R3™ Acetabular System
89.3
± 10.69
Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)Secondary· Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit.
Pre-operative
Group
Value
95% CI
R3™ Acetabular System
51.5
± 14.25
3 Months
Group
Value
95% CI
R3™ Acetabular System
85.5
± 13.78
1 Year
Group
Value
95% CI
R3™ Acetabular System
92.2
± 11.67
3 Years
Group
Value
95% CI
R3™ Acetabular System
92.2
± 10.91
5 Years
Group
Value
95% CI
R3™ Acetabular System
93.1
± 10.93
7 Years
Group
Value
95% CI
R3™ Acetabular System
92.3
± 10.90
10 Years
Group
Value
95% CI
R3™ Acetabular System
92.5
± 10.71
Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) RatingSecondary· Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years
UCLA Activity Score is a measure of physical activity levels in participants undergoing total joint arthroplasty. The scale ranges from 1 to 10 with higher scores indicating greater physical function (i.e., a better outcome).
Pre-operative
Group
Value
95% CI
R3™ Acetabular System
3.4
± 1.35
3 Months
Group
Value
95% CI
R3™ Acetabular System
5.2
± 1.56
1 Year
Group
Value
95% CI
R3™ Acetabular System
6.1
± 1.58
3 Years
Group
Value
95% CI
R3™ Acetabular System
6.1
± 1.66
5 Years
Group
Value
95% CI
R3™ Acetabular System
6.1
± 1.66
7 Years
Group
Value
95% CI
R3™ Acetabular System
5.7
± 1.61
10 Years
Group
Value
95% CI
R3™ Acetabular System
5.6
± 1.71
Radiographic Findings: AtrophySecondary· 1 years, 3 years, 5 years, 7 years, 10 years
Number of participant hips with radiographic findings for atrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years for the following:
* Atrophy in any Cup Zones
* Atrophy in any Stem Zones
1 Year: Atrophy in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
431
R3™ Acetabular System
0
R3™ Acetabular System
0
1 Year: Atrophy in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
428
R3™ Acetabular System
3
R3™ Acetabular System
0
3 Years: Atrophy in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
413
R3™ Acetabular System
0
R3™ Acetabular System
0
3 Years: Atrophy in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
411
R3™ Acetabular System
2
R3™ Acetabular System
0
5 Years: Atrophy in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
357
R3™ Acetabular System
0
R3™ Acetabular System
0
5 Years: Atrophy in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
357
R3™ Acetabular System
0
R3™ Acetabular System
0
7 Years: Atrophy in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
334
R3™ Acetabular System
0
R3™ Acetabular System
0
7 Years: Atrophy in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
332
R3™ Acetabular System
2
R3™ Acetabular System
0
Radiographic Findings: HypertrophySecondary· 1 years, 3 years, 5 years, 7 years, 10 years
Number of participant hips with radiographic findings for hypertrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years for the following:
* Hypertrophy in any Cup Zones
* Hypertrophy in any Stem Zones
1 Year: Hypertrophy in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
427
R3™ Acetabular System
4
R3™ Acetabular System
0
1 Year: Hypertrophy in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
399
R3™ Acetabular System
32
R3™ Acetabular System
0
3 Years: Hypertrophy in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
412
R3™ Acetabular System
1
R3™ Acetabular System
0
3 Years: Hypertrophy in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
350
R3™ Acetabular System
63
R3™ Acetabular System
0
5 Years: Hypertrophy in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
357
R3™ Acetabular System
0
R3™ Acetabular System
0
5 Years: Hypertrophy in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
347
R3™ Acetabular System
10
R3™ Acetabular System
0
7 Years: Hypertrophy in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
334
R3™ Acetabular System
0
R3™ Acetabular System
0
7 Years: Hypertrophy in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
325
R3™ Acetabular System
9
R3™ Acetabular System
0
Radiographic Findings: OsteolysisSecondary· 1 years, 3 years, 5 years, 7 years, 10 years
Number of participant hips with radiographic findings for osteolysis greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years as the following:
* Osteolysis \> 2mm in any Cup Zones
* Osteolysis \> 2mm in any Stem Zones
1 Year: Osteolysis > 2mm in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
403
R3™ Acetabular System
4
R3™ Acetabular System
24
1 Year: Osteolysis > 2mm in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
401
R3™ Acetabular System
5
R3™ Acetabular System
25
3 Years: Osteolysis > 2mm in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
383
R3™ Acetabular System
6
R3™ Acetabular System
24
3 Years: Osteolysis > 2mm in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
380
R3™ Acetabular System
7
R3™ Acetabular System
26
5 Years: Osteolysis > 2mm in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
326
R3™ Acetabular System
6
R3™ Acetabular System
25
5 Years: Osteolysis > 2mm in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
326
R3™ Acetabular System
4
R3™ Acetabular System
27
7 Years: Osteolysis > 2mm in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
322
R3™ Acetabular System
2
R3™ Acetabular System
10
7 Years: Osteolysis > 2mm in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
317
R3™ Acetabular System
7
R3™ Acetabular System
10
Radiographic Findings: Radiolucent Lines (RLL)Secondary· 1 years, 3 years, 5 years, 7 years, 10 years
Number of participant hips with radiographic findings for radiolucent lines (RLL) greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, \& 10 years as the following:
* RLL \> 2mm in any Cup Zones
* RLL \> 2mm in any Stem Zones
1 Year: RLL > 2mm in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
431
R3™ Acetabular System
0
R3™ Acetabular System
0
1 Year: RLL > 2mm in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
430
R3™ Acetabular System
1
R3™ Acetabular System
0
3 Years: RLL > 2mm in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
413
R3™ Acetabular System
0
R3™ Acetabular System
0
3 Years: RLL > 2mm in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
413
R3™ Acetabular System
0
R3™ Acetabular System
0
5 Years: RLL > 2mm in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
356
R3™ Acetabular System
1
R3™ Acetabular System
0
5 Years: RLL > 2mm in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
357
R3™ Acetabular System
0
R3™ Acetabular System
0
7 Years: RLL > 2mm in any Cup Zones
Group
Value
95% CI
R3™ Acetabular System
333
R3™ Acetabular System
1
R3™ Acetabular System
0
7 Years: RLL > 2mm in any Stem Zones
Group
Value
95% CI
R3™ Acetabular System
334
R3™ Acetabular System
0
R3™ Acetabular System
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected following implantation of the R3™ Acetabular System through 10 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
R3™ Acetabular System
Serious: 371/478 (78%)
Deaths: 37/478
Serious adverse events (69 terms)
Reaction
System
R3™ Acetabular System
Skeletal
Musculoskeletal and connective tissue disorders
—
Cancer, known origin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Circulatory
Cardiac disorders
—
Digestive/Gastrointestinal
Gastrointestinal disorders
—
Eye/Adnexa
Eye disorders
—
Nervous
Nervous system disorders
—
Circulatory
Vascular disorders
—
Respiratory
Respiratory, thoracic and mediastinal disorders
—
Urinary
Renal and urinary disorders
—
Muscular/Connective Tissue
Musculoskeletal and connective tissue disorders
—
Reaction to metal debris/ metal allergy
Injury, poisoning and procedural complications
—
Endocrine/Nutritional/Metabolic
Metabolism and nutrition disorders
—
Infection
Infections and infestations
—
Reproductive System
Reproductive system and breast disorders
—
Skin/Subcutaneous Tissue
Skin and subcutaneous tissue disorders
—
Bone Fracture- Femur
Musculoskeletal and connective tissue disorders
—
Injury, poisoning, or consequence of external causes
Injury, poisoning and procedural complications
—
Endocrine/Nutritional/Metabolic
Endocrine disorders
—
Hematologic/Immune System
Vascular disorders
—
Mental/behavioral
Psychiatric disorders
—
Pain in study hip
Injury, poisoning and procedural complications
—
Dislocation
Musculoskeletal and connective tissue disorders
—
Digestive/Gastrointestinal
Musculoskeletal and connective tissue disorders
—
Leg Length Change
Injury, poisoning and procedural complications
—
Femoral Component
Product Issues
—
Other adverse events (79 terms — click to expand)
Reaction
System
R3™ Acetabular System
Skeletal
Musculoskeletal and connective tissue disorders
—
Muscular/Connective Tissue
Musculoskeletal and connective tissue disorders
—
Digestive/Gastrointestinal
Gastrointestinal disorders
—
Nervous
Nervous system disorders
—
Skin/Subcutaneous Tissue
Skin and subcutaneous tissue disorders
—
Respiratory
Respiratory, thoracic and mediastinal disorders
—
Urinary
Renal and urinary disorders
—
Circulatory
Vascular disorders
—
Pain in study hip
Injury, poisoning and procedural complications
—
Elevated Metal Ions
Injury, poisoning and procedural complications
—
Ear/Mastoid Process
Ear and labyrinth disorders
—
Mental/behavioral
Psychiatric disorders
—
Endocrine/Nutritional/Metabolic
Metabolism and nutrition disorders
—
Injury, poisoning, or consequence of external causes
Injury, poisoning and procedural complications
—
Circulatory
Cardiac disorders
—
Hematologic/Immune System
Vascular disorders
—
Heterotopic Ossification: Grade I
Musculoskeletal and connective tissue disorders
—
Eye/Adnexa
Eye disorders
—
Infection
Infections and infestations
—
Reproductive System
Reproductive system and breast disorders
—
Endocrine/Nutritional/Metabolic
Endocrine disorders
—
Trochanteritis
Injury, poisoning and procedural complications
—
Cancer, known origin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Pain, unknown etiology
Nervous system disorders
—
Lymphatic
Blood and lymphatic system disorders
—
Pain, unknown etiology
Musculoskeletal and connective tissue disorders
—
Groin pain, study hip side
Injury, poisoning and procedural complications
—
Hip Discomfort, soreness, or cramping, may be intermittent
Injury, poisoning and procedural complications
—
Reaction to metal debris/ metal allergy
Injury, poisoning and procedural complications
—
Bursitis
Injury, poisoning and procedural complications
—
Pseudotumor
Injury, poisoning and procedural complications
—
Pain, unknown etiology
General disorders
—
Endocrine/Nutritional/Metabolic
Musculoskeletal and connective tissue disorders
—
Leg Pain
Injury, poisoning and procedural complications
—
Pain at Op site
Injury, poisoning and procedural complications
—
Post-op swelling of study leg
Injury, poisoning and procedural complications
—
Hematoma, Hemarthrosis
Injury, poisoning and procedural complications
—
Hip Squeaking/Clicking/Popping/Snapping or other noise
The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.
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 Orthopaedics AG
Last refreshed: 11 April 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/NCT04399928.