N/A
N=20
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
Osteoarthritis, Hip
Bottom Line
View on ClinicalTrials.gov: NCT01066936 ↗Enrolled (actual)
20
Serious AEs
65.0%
Results posted
Mar 2020
Primary outcome: Primary: DEXA Analysis of BMD at Preoperative Visit — 0.8; 1.0; 1.6; 2.0 g/cm^2
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DEXA Analysis of BMD at Preoperative Visit |
0.8; 1.0; 1.6; 2.0; 1.8; 1.3 | — |
| PRIMARY DEXA Analysis of BMD at 3 Months |
0.8; 1.3; 2.1; 1.9; 1.9; 1.5 | — |
| PRIMARY DEXA Analysis of BMD at 6 Months |
0.8; 1.3; 2.1; 1.9; 2.0; 1.6 | — |
| PRIMARY DEXA Analysis of BMD at 1 Year |
0.8; 1.3; 2.1; 1.9; 1.9; 1.6 | — |
| PRIMARY DEXA Analysis of BMD at 2 Years |
0.8; 1.3; 2.2; 1.9; 2.0; 1.6 | — |
| SECONDARY Baseline Harris Hip Score (HHS) at Preoperative Visit |
17.0; 26.0; 3.8; 2.7; 49.5 | — |
| SECONDARY Harris Hip Score (HHS) at 3 Month Visit |
37.5; 35.1; 4.0; 4.1; 82.6 | — |
| SECONDARY Harris Hip Score (HHS) at 6 Month Visit |
40.8; 41.2; 4.0; 4.2; 90.1 | — |
| SECONDARY Harris Hip Score (HHS) at 1 Year Visit |
38.0; 41.5; 4.0; 4.5; 87.3 | — |
| SECONDARY Harris Hip Score (HHS) at 2 Year Visit |
40.7; 41.9; 4.0; 4.0; 90.6 | — |
| SECONDARY Harris Hip Score (HHS) at 5 Year Visit |
43.6; 45.8; 4.0; 4.3; 97.7 | — |
| SECONDARY Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit |
52.8; 49.1; 44.7; 22.1; 24.7 | — |
| SECONDARY Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit |
83.0; 88.8; 84.8; 76.0; 73.1 | — |
| SECONDARY Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit |
93.0; 94.2; 93.0; 80.4; 83.8 | — |
| SECONDARY Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit |
90.0; 89.2; 87.8; 78.3; 82.4 | — |
| SECONDARY Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit |
90.7; 92.5; 89.9; 81.6; 81.7 | — |
| SECONDARY Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit |
96.5; 98.3; 97.2; 85.6; 95.8 | — |
| SECONDARY Radiographic Assessment at Preoperative Visit (Yes/No Components) |
20; 0; 0; 20; 0; 20 | — |
| SECONDARY Radiographic Assessment at 3 Month Visit (Yes/No Components) |
20; 0; 0; 20; 0; 20 | — |
| SECONDARY Radiographic Assessment at 1 Year Visit (Yes/No Components) |
19; 1; 0; 20; 1; 19 | — |
| SECONDARY Radiographic Assessment at 5 Year Visit (Yes/No Components) |
10; 0; 0; 10; 0; 10 | — |
| SECONDARY Radiographic Assessment at Discharge Visit |
0; 40.9 | — |
| SECONDARY Radiographic Assessment at 3 Month Visit |
0; 41.3 | — |
| SECONDARY Radiographic Assessment at 1 Year Visit |
0; 41.3 | — |
| SECONDARY Radiographic Assessment at 5 Year Visit |
10.5; 40.6 | — |
| SECONDARY Radiographic Assessment at Discharge Visit (Neutral/Valgus Component) |
20; 0 | — |
| SECONDARY Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component) |
20; 0 | — |
| SECONDARY Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component) |
20; 0 | — |
| SECONDARY Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component) |
8; 2 | — |
Summary
The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.
Eligibility Criteria
Inclusion Criteria
- Patient has hip disease that requires a total hip arthroplasty.
- Patient is willing to consent to participate in the study.
- Patient plans to be available for the study duration.
- Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
Exclusion Criteria
- Patient known to have insufficient bone stock.
- Patient has had major non-arthroscopic surgery to the study hip.
- Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
- Patient has a known sensitivity to materials in the device.
Data sourced from ClinicalTrials.gov (NCT01066936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.