N/A
Completed N=41
Mini Stem Radiostereometric Analysis Study
Osteoarthritis, Hip
Source: ClinicalTrials.gov NCT01064531 ↗
Enrolled (actual)
41
Serious AEs
14.6%
Results posted
Apr 2020
Primary outcomePrimary: Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) — 0.204; 0.224; -0.942; -0.322 mm
Summary
The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations.
Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Translational Movement) |
0.204; 0.224; -0.942; -0.322; -0.031; -0.328 | — |
| PRIMARY Migration of the MIS Femoral Neck Stem Compared to the Synergy Hip System Using RSA (Rotational Movement) |
-0.475; -0.006; 0.958; 1.414; -0.463; -0.091 | — |
| SECONDARY Preoperative Total Harris Hip Score (HHS) |
0; 0; 1; 0; 1; 1 | — |
| SECONDARY 3 Months Postoperative Total Harris Hip Score (HHS) |
10; 7; 6; 6; 3; 1 | — |
| SECONDARY 1 Year Postoperative Total Harris Hip Score (HHS) |
15; 10; 6; 2; 0; 2 | — |
| SECONDARY 2 Years Postoperative Total Harris Hip Score (HHS) |
14; 7; 4; 6; 2; 3 | — |
| SECONDARY 3 Years Postoperative Total Harris Hip Score (HHS) |
12; 9; 2; 1; 0; 2 | — |
| SECONDARY 5 Years Postoperative Total Harris Hip Score (HHS) |
9; 8; 4; 3; 3; 0 | — |
| SECONDARY Preoperative Hip Disability Osteoarthritis Outcome Score (HOOS) |
47.4; 40.5; 37.1; 33.5; 41.0; 33.4 | — |
| SECONDARY 3 Months Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) |
81.8; 77.2; 85.1; 76.9; 81.9; 76.0 | — |
| SECONDARY 1 Year Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) |
87.9; 81.0; 85.0; 80.8; 85.1; 76.0 | — |
| SECONDARY 2 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) |
87.9; 82.2; 84.2; 81.7; 82.4; 72.1 | — |
| SECONDARY 3 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) |
88.0; 81.9; 84.0; 85.8; 86.0; 73.0 | — |
| SECONDARY 5 Years Postoperative Hip Disability Osteoarthritis Outcome Score (HOOS) |
85.3; 84.4; 81.2; 78.1; 76.7; 71.0 | — |
| SECONDARY Preoperative Radiographic Assessments |
21; 20; 0; 0; 0; 0 | — |
| SECONDARY 3 Months Postoperative Radiographic Assessments |
19; 16; 0; 0; 0; 0 | — |
| SECONDARY 1 Year Postoperative Radiographic Assessments |
15; 11; 5; 4; 0; 0 | — |
| SECONDARY 2 Years Postoperative Radiographic Assessments |
11; 12; 10; 4; 0; 0 | — |
| SECONDARY 3 Years Postoperative Radiographic Assessments |
8; 7; 7; 6; 0; 0 | — |
| SECONDARY 5 Years Postoperative Radiographic Assessments |
13; 11; 4; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has hip disease that requires a total hip arthroplasty.
- Subject is willing to consent to participation in the study.
- Subject plans to be available for follow-up through study duration.
- Subject is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk.
Exclusion Criteria
- Subject has insufficient femoral bone stock.
- Subject has had major non-arthroscopic surgery to the study hip.
- Subject has physical, emotional or neurological conditions that would compromise the subjects compliance with postoperative rehabilitation and follow-up.
- Subject has a known sensitivity to materials in the device.
Data sourced from ClinicalTrials.gov (NCT01064531). 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. Informational only — not medical advice.