Clinical trial NCT05144191: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Post-traumatic Osteoarthritis
Femoral Neck Fractures
Trochanteric Fractures
Surgery
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2021-12-03
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Survival Rate
timeFrame: 10 years
measure: Harris Hip Score (HHS)
timeFrame: 10 Years
Secondary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: pre-op, 6 week, 1,2,5 and 7 years
measure: EQ-5D - Descriptive System
timeFrame: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
measure: EQ-5D - Visual analogue scale (VAS)
timeFrame: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
measure: Survival Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The MORE Foundation
state: Arizona
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Reno
country: United States
facility: Reno Orthopedic Center Foundation
state: Nevada
city: Great Neck
country: United States
facility: Northwell Health: University Orthopaedic Associates
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Pittsburgh
country: United States
facility: Alleghany Health Network- Research Institute
state: Pennsylvania
city: Nashville
country: United States
facility: TOA Research Foundation
state: Tennessee
city: Temple
country: United States
facility: Baylor Scott and White Medical Center
state: Texas
city: Seattle
country: United States
facility: Orthopedic Physician Associates
state: Washington
city: Spokane
country: United States
facility: Providence Orthopedics and Sports Medicine
state: Washington
Study officials:
References: