Insignia™ Hip Stem Outcomes Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgery, Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Femoral Neck Fractures, Trochanteric Fractures

Intervention / Treatment
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* Device: Insignia uncemented Hip Stem


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Insignia uncemented Hip Stem<br>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<br>* Device: Replacement of arthritic hip with Insignia uncemented Hip Stem<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |