Insignia™ Hip Stem Outcomes Study
Primary Purpose
Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insignia uncemented Hip Stem
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Reno Orthopedic Center FoundationRecruiting
- Toomey Orthopedic Research Institute, PLLCRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Insignia uncemented Hip Stem
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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
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.
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).
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%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05144191
Brief Title
Insignia™ Hip Stem Outcomes Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
January 5, 2033 (Anticipated)
Study Completion Date
January 5, 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Femoral Neck Fractures, Trochanteric Fractures, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
313 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Insignia uncemented Hip Stem
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Insignia uncemented Hip Stem
Intervention Description
Device: Replacement of arthritic hip with Insignia uncemented Hip Stem
Primary Outcome Measure Information:
Title
Survival Rate
Description
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
Title
Harris Hip Score (HHS)
Description
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
Secondary Outcome Measure Information:
Title
Harris Hip Score (HHS)
Description
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
Title
EQ-5D - Descriptive System
Description
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
Title
EQ-5D - Visual analogue scale (VAS)
Description
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).
Time Frame
pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
Title
Survival Rate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Davis
Phone
201-831-5000
Email
barbara.davis@stryker.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Barga
Phone
201 831 5073
Email
kevin.barga@stryker.com
Facility Information:
Facility Name
Reno Orthopedic Center Foundation
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara DePaoli
Email
sdepaoli@renoortho.com
First Name & Middle Initial & Last Name & Degree
Sanjai Shukla, MD
First Name & Middle Initial & Last Name & Degree
Chad Watts, MD
Facility Name
Toomey Orthopedic Research Institute, PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clyde Pruett
Email
cpruett@proliancesurgeons.com
First Name & Middle Initial & Last Name & Degree
Sean Toomey, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Insignia™ Hip Stem Outcomes Study
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