Avascular Necrosis, Femoral Neck Fractures, Hip Osteoarthritis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis, Surgery, Trochanteric Fractures
Conditions
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.
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.
Interventions
DEVICEInsignia uncemented Hip Stem
Device: Replacement of arthritic hip with Insignia uncemented Hip Stem
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
Countries
United States
Outcome results
None listed