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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
313
Device: Replacement of arthritic hip with Insignia uncemented Hip Stem
The MORE Foundation
Phoenix, Arizona, United States
University of California, San Francisco
San Francisco, California, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, United States
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.
Time frame: 10 years
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
Time frame: 10 Years
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
Time frame: pre-op, 6 week, 1,2,5 and 7 years
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.
Time frame: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Reno Orthopedic Center Foundation
Reno, Nevada, United States
Northwell Health: University Orthopaedic Associates
Great Neck, New York, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Alleghany Health Network- Research Institute
Pittsburgh, Pennsylvania, United States
TOA Research Foundation
Nashville, Tennessee, United States
Baylor Scott and White Medical Center
Temple, Texas, United States
Orthopedic Physician Associates
Seattle, Washington, United States
...and 1 more locations
Time frame: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
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%.
Time frame: 2 years