Rheumatoid Arthritis Clinical Trial
Official title:
Insignia™ Hip Stem Outcomes Study - A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia™ Hip Stem for Total Hip Replacement Surgery
NCT number | NCT05144191 |
Other study ID # | 107 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 7, 2022 |
Est. completion date | December 31, 2034 |
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.
Status | Recruiting |
Enrollment | 313 |
Est. completion date | December 31, 2034 |
Est. primary completion date | December 31, 2033 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - The subject has signed an Institutional Review Board (IRB)-approved, study specific Informed Consent Form (ICF). - The subject is skeletally mature - 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. - The subject is a candidate for a primary or revision cementless THA. - The subject is willing and able to comply with postoperative scheduled clinical evaluations. Exclusion Criteria: - The subject is pregnant or breastfeeding - The subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation. - 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. - The subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. - The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days). - The subject has a known sensitivity to device materials. - The subject is involved in any ongoing legal matter, investigation, or dispute pertaining to the operative site. - The subject is a prisoner. |
Country | Name | City | State |
---|---|---|---|
United States | Reno Orthopedic Center Foundation | Reno | Nevada |
United States | Toomey Orthopedic Research Institute, PLLC | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Stryker Orthopaedics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival Rate | 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. | 10 years | |
Primary | Harris Hip Score (HHS) | 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 |
10 Years | |
Secondary | Harris Hip Score (HHS) | 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 |
pre-op, 6 week, 1,2,5 and 7 years | |
Secondary | EQ-5D - Descriptive System | 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. |
pre-op, 6 week, 1,2,3, 4,5,7 and 10 years | |
Secondary | EQ-5D - Visual analogue scale (VAS) | 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). |
pre-op, 6 week, 1,2,3, 4,5,7 and 10 years | |
Secondary | Survival Rate | 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%. |
2 years |
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