Insignia™ Hip Stem Outcomes Study
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study is a prospective, post-market, multi-center clinical investigation of the Insignia™ Hip Stem for primary and revision total hip arthroplasty (THA) in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is a minimum of 313 cases, all of which will receive the Insignia™ Hip Stem.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Insignia uncemented Hip Stem The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Insignia™ Hip Stems are intended for 'cement less' use only and are intended for total arthroplasty procedures. |
Device: Insignia uncemented Hip Stem
Device: Replacement of arthritic hip with Insignia uncemented Hip Stem
|
Outcome Measures
Primary Outcome Measures
- Survival Rate [10 years]
Evaluation of the survival rate for Insignia Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture.
- Harris Hip Score (HHS) [10 Years]
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Secondary Outcome Measures
- Harris Hip Score (HHS) [pre-op, 6 week, 1,2,5 and 7 years]
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
- EQ-5D - Descriptive System [pre-op, 6 week, 1,2,3, 4,5,7 and 10 years]
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.
- EQ-5D - Visual analogue scale (VAS) [pre-op, 6 week, 1,2,3, 4,5,7 and 10 years]
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. With the EQ Visual Analogue Scale (VAS) the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
- Survival Rate [2 years]
Evaluation of the survival rate for Insignia™ Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture Success rate at two (2) years postoperative with the Insignia™ Hip Stem is not worse than 98 % with a non-inferiority margin of 3.5%. Success rate at 10 years postoperative with the Insignia™ Hip Stem is not worse than 95% with a non-inferiority margin of 5%.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The subject has signed an Institutional Review Board (IRB)-approved, study specific Informed Consent Form (ICF).
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The subject is skeletally mature
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The subject has a diagnosis as listed in the instructions for use (IFU), which include non inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, correction of functional deformity, treatment of nonunion, femoral neck and trochanteric fractures.
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The subject is a candidate for a primary or revision cementless THA.
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The subject is willing and able to comply with postoperative scheduled clinical evaluations.
Exclusion Criteria:
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The subject is pregnant or breastfeeding
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The subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation.
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The subject has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
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The subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
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The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
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The subject has a known sensitivity to device materials.
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The subject is involved in any ongoing legal matter, investigation, or dispute pertaining to the operative site.
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The subject is a prisoner.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Reno Orthopedic Center Foundation | Reno | Nevada | United States | 89503 |
| 2 | Toomey Orthopedic Research Institute, PLLC | Seattle | Washington | United States | 98122 |
Sponsors and Collaborators
- Stryker Orthopaedics
Investigators
- Study Director: Shaherah Yancy, Stryker Joint Replacement Clinical Operations
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 107