Trial Outcomes & Findings for OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study (NCT NCT02353377)
NCT ID: NCT02353377
Last Updated: 2026-03-19
Results Overview
To be classified as overall success, the participant must meet all of the following criteria: * Clinical Success * Harris Hip Score of 80 or more at the 730-day follow-up time point. * Radiologic success at the 730-day follow-up time point defined as: * No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones, and * No femoral or acetabular subsidence greater than or equal to 5mm from baseline, and * No acetabular cup inclination changes greater than 4 degrees. * Absence of Revision * No reoperations that led to removal or replacement of any of the acetabular or femoral components
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
413 participants
Primary outcome timeframe
730 days
Results posted on
2026-03-19
Participant Flow
Participant milestones
| Measure |
OXINIUM DH Hip System
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
208
|
|
Overall Study
COMPLETED
|
170
|
152
|
|
Overall Study
NOT COMPLETED
|
35
|
56
|
Reasons for withdrawal
| Measure |
OXINIUM DH Hip System
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
31
|
52
|
|
Overall Study
Removal/revision of device
|
3
|
3
|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study
Baseline characteristics by cohort
| Measure |
OXINIUM DH Hip System
n=205 Participants
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=208 Participants
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 9.1 • n=110 Participants
|
56.9 years
STANDARD_DEVIATION 9.6 • n=114 Participants
|
57.6 years
STANDARD_DEVIATION 9.3 • n=224 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=110 Participants
|
119 Participants
n=114 Participants
|
230 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=110 Participants
|
89 Participants
n=114 Participants
|
183 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
6 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
21 Participants
n=110 Participants
|
21 Participants
n=114 Participants
|
42 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
176 Participants
n=110 Participants
|
178 Participants
n=114 Participants
|
354 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
11 Participants
n=224 Participants
|
|
Body Mass Index (BMI)
|
28.3 kg/m^2
STANDARD_DEVIATION 4.9 • n=110 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 5.0 • n=114 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 4.9 • n=224 Participants
|
|
Medical History - Primary Diagnosis
Osteoarthritis
|
195 Participants
n=110 Participants
|
197 Participants
n=114 Participants
|
392 Participants
n=224 Participants
|
|
Medical History - Primary Diagnosis
Traumatic arthritis
|
2 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
7 Participants
n=224 Participants
|
|
Medical History - Primary Diagnosis
Avascular necrosis
|
5 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
9 Participants
n=224 Participants
|
|
Medical History - Primary Diagnosis
Other
|
3 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
5 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: 730 daysPopulation: Unilateral hip implant participants with data collected for the outcome and time frame indicated
To be classified as overall success, the participant must meet all of the following criteria: * Clinical Success * Harris Hip Score of 80 or more at the 730-day follow-up time point. * Radiologic success at the 730-day follow-up time point defined as: * No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones, and * No femoral or acetabular subsidence greater than or equal to 5mm from baseline, and * No acetabular cup inclination changes greater than 4 degrees. * Absence of Revision * No reoperations that led to removal or replacement of any of the acetabular or femoral components
Outcome measures
| Measure |
OXINIUM DH Hip System
n=198 Participants
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=204 Participants
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Overall Success at 730 Days Post-operative in Participants With a Unilateral Hip Implant
|
55 Participants
|
47 Participants
|
PRIMARY outcome
Timeframe: 730 daysPopulation: Overall number of unilateral hip implant participants with data collected for the time frame indicated.
The number of participants with a modified Harris Hip Score (mHHS) greater than or equal to 80 points. The Harris Hip Score (HHS) is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. The mHHS includes all the same domains as the HHS except for the hip range of motion. Total mHHS scale ranged from 0 (worst) to 95 (best).
Outcome measures
| Measure |
OXINIUM DH Hip System
n=163 Participants
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=144 Participants
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Number of Unilateral Hip Implant Participants With Modified Harris Hip Score Greater Than or Equal to 80 Points
|
144 Participants
|
136 Participants
|
PRIMARY outcome
Timeframe: 730 daysPopulation: Overall number of unilateral hip implant participants with data collected for the time frame indicated.
Number of participants with radiographic success for radiolucencies where success indicated no radiolucencies greater than 2 millimeters (mm) in 50% or more in any of the cup or stem zones.
Outcome measures
| Measure |
OXINIUM DH Hip System
n=155 Participants
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=140 Participants
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Radiographic Success at 730 Days Postoperative - Radiolucencies in Participants With a Unilateral Hip Implant
|
150 Participants
|
136 Participants
|
PRIMARY outcome
Timeframe: 730 daysPopulation: Overall number of unilateral hip implant participants with data collected for the time frame indicated.
Number of participants with radiographic success for femoral or acetabular subsidence where success indicated no femoral or acetabular subsidence greater than or equal to 5 millimeters (mm) from baseline.
Outcome measures
| Measure |
OXINIUM DH Hip System
n=155 Participants
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=140 Participants
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Radiographic Success at 730 Days Postoperative - Femoral or Acetabular Subsidence in Participants With a Unilateral Hip Implant
|
154 Participants
|
140 Participants
|
PRIMARY outcome
Timeframe: 730 daysPopulation: Overall number of unilateral hip implant participants with data collected for the time frame indicated.
Number of participants with radiographic success for acetabular cup inclination where success indicated no acetabular cup inclination changes greater than 4 degrees.
Outcome measures
| Measure |
OXINIUM DH Hip System
n=198 Participants
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=204 Participants
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Radiographic Success at 730 Days Postoperative - Acetabular Cup Inclination in Participants With a Unilateral Hip Implant
|
84 Participants
|
88 Participants
|
PRIMARY outcome
Timeframe: 730 DaysPopulation: Overall number of unilateral hip implant participants with data collected for the time frame indicated.
Number of participants with absence of revision defined as no reoperations that led to removal or replacement of any of the acetabular or femoral components.
Outcome measures
| Measure |
OXINIUM DH Hip System
n=166 Participants
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=151 Participants
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Number of Unilateral Hip Implant Participants With Absence of Revision at 730 Days Postoperative
|
163 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: Baseline to 730 daysPopulation: Overall number of participants with data collected for the time frame indicated.
The WOMAC is a 24 item subject-reported self-assessment questionnaire. It evaluates pain (5 questions), stiffness (2 questions), and functional limitation (17 questions) in knee and hip osteoarthritis. In this study, version 3.0 of the instrument is used, which employs a 5-point Likert scale ranging from none (0) to extreme (4). The Functional Limitations Score takes values from 0 (no problems) to 68 (extreme problems). Scores are transformed to a score from 0 to 100, with a lower score indicating a better outcome.
Outcome measures
| Measure |
OXINIUM DH Hip System
n=167 Participants
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=150 Participants
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 730 Days Postoperatively
|
7.37 score on a scale
Standard Deviation 11.39
|
6.32 score on a scale
Standard Deviation 11.48
|
Adverse Events
OXINIUM DH Hip System
Serious events: 56 serious events
Other events: 114 other events
Deaths: 1 deaths
BIOLOX◊
Serious events: 41 serious events
Other events: 92 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
OXINIUM DH Hip System
n=205 participants at risk
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=208 participants at risk
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Musculoskeletal and Connective Tissue Disorders
Bone Fracture- Femur
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Product Issues
Femoral
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Musculoskeletal and Connective Tissue Disorders
Superficial Infection Only
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Product Issues
Implant Failure
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Deep Vein Thrombosis
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Wound Dehiscence
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, poisoning and procedural complications
Inflammation
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Cellulitis
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Pseudotumor
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Elevated Metal Ions
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Iliopsis tendinitis, iliopsis snapping, coxa sultans
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Pain in study hip
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Vascular Disorders
Circulatory
|
3.9%
8/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
1.4%
3/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Hepatobiliary Disorders
Digestive/Gastrointestinal
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
1.9%
4/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Metabolism and Nutrition Disorders
Endocrine/Nutritional/Metabolic
|
2.0%
4/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Musculoskeletal and Connective Tissue Disorders
Muscular/Connective Tissue (generic musculoskeletal)
|
7.3%
15/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
3.8%
8/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Nervous System Disorders
Nervous
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Reproductive System and Breast Disorders
Reproductive System
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Respiratory, Thoracic and Mediastinal Disorders
Respiratory
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
1.4%
3/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Musculoskeletal and Connective Tissue Disorders
Skeletal
|
7.3%
15/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
3.8%
8/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Renal and Urinary Disorders
Genitourinary
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Infections and Infestations
Infection
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Psychiatric Disorders
Mental/behavioral
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Skin and Subcutaneous Tissue Disorders
Skin/Subcutaneous Tissue
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Poisoning/Injury of External Cause
|
2.4%
5/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Musculoskeletal and Connective Tissue Disorders
Pain, unknown etiology
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
2.4%
5/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps)
Cancer, unknown type
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps)
Cancer, known origin
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Injury, poisoning, or consequence of external causes
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
Other adverse events
| Measure |
OXINIUM DH Hip System
n=205 participants at risk
Oxinium DH◊ Hip System (Smith \& Nephew), Smith \& Nephew R3◊ acetabular shell and ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
OXINIUM DH Hip System: Investigational Group: OXINIUM DH Hip System
|
BIOLOX◊
n=208 participants at risk
BIOLOX◊ delta ceramic heads and XLPE liners; R3◊ acetabular shell, ANTHOLOGY◊, SYNERGY◊ OR POLARSTEM◊ un-cemented femoral stem.
BIOLOX◊: Control Group: BIOLOX◊ delta ceramic heads and XLPE liners
|
|---|---|---|
|
Injury, Poisoning and Procedural Complications
Disturbance of skin sensation
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Leg Pain
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Renal and Urinary Disorders
Genitourinary
|
2.9%
6/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
5.3%
11/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Hip Squeaking/Clicking/Popping/Snapping or other noise
|
14.1%
29/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
8.7%
18/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Rash or redness (at op site only)
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Bursitis
|
2.9%
6/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
4.8%
10/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Tendonitis
|
1.5%
3/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Blisters at operative site
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Leg and buttock pain, soreness, numbness
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Product Issues
Femoral Component
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Product Issues
Both femoral and acetabular
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Musculoskeletal and Connective Tissue Disorders
Subluxation, no comp. specified
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Nerve Injury
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Wound Dehiscence
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Hematoma, Hemarthrosis
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, poisoning and procedural complications
Inflammation
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Stitch Abcess
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Fluid Accumulation in Bursal Sac
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Stiffness
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Elevated Metal Ions
|
1.5%
3/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Post-op swelling of study leg
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Operative side pain originating from other than study hip
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Iliopsis tendinitis, iliopsis snapping, coxa sultans
|
1.5%
3/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Pain in study hip
|
4.9%
10/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
3.8%
8/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Non-specific twinges, feelings in study hip
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Groin pain, study hip side
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Cyst
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Antalgic gait
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Buttock pain/soreness/discomfort
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Stress Shielding
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Weakness in study leg
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Perioperative Pulmonary Embolism
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Myalgia, muscle pain
|
0.00%
0/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Vascular Disorders
Circulatory
|
7.3%
15/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
3.8%
8/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Hepatobiliary Disorders
Digestive/Gastrointestinal
|
5.9%
12/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
2.9%
6/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Metabolism and Nutrition Disorders
Endocrine/Nutritional/Metabolic
|
2.4%
5/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
2.4%
5/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Blood and Lymphatic System Disorders
Lymphatic
|
1.5%
3/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Musculoskeletal and Connective Tissue Disorders
Muscular/Connective Tissue (generic musculoskeletal)
|
23.9%
49/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
20.2%
42/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Nervous System Disorders
Nervous
|
4.9%
10/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
2.9%
6/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Reproductive System and Breast Disorders
Reproductive System
|
2.9%
6/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
1.4%
3/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Respiratory, Thoracic and Mediastinal Disorders
Respiratory
|
4.4%
9/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
5.3%
11/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Musculoskeletal and Connective Tissue Disorders
Skeletal
|
11.2%
23/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
8.2%
17/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Nervous System Disorders
Special Sense
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Infections and Infestations
Infection
|
5.4%
11/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
4.8%
10/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Psychiatric Disorders
Mental/behavioral
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Eye Disorders
Eye/Adnexa
|
0.98%
2/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.96%
2/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Ear and Labyrinth Disorders
Ear/Mastoid Process
|
2.0%
4/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
1.4%
3/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Vascular Disorders
Hematologic/Immune System
|
1.5%
3/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
1.4%
3/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Skin and Subcutaneous Tissue Disorders
Skin/Subcutaneous Tissue
|
5.9%
12/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
3.4%
7/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Poisoning/Injury of External Cause
|
3.4%
7/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
1.4%
3/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Musculoskeletal and Connective Tissue Disorders
Pain, unknown etiology
|
10.2%
21/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
12.5%
26/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps)
Cancer, unknown type
|
0.49%
1/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.00%
0/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Psychiatric Disorders
Not otherwise defined
|
2.0%
4/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
0.48%
1/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
|
Injury, Poisoning and Procedural Complications
Injury, poisoning, or consequence of external causes
|
3.9%
8/205 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
2.4%
5/208 • Adverse events reported for this analysis were collected from surgery to the 2-year primary completion visit, approximately 730 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 90 days but less than or equal to 180 days from the time submitted to the sponsor for review. Sponsor may delay publication up to 180 days to permit the filing of appropriate patent applications if the sponsor believes any publication contains any information relating to patentable items and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER