Insignia™ Hip Stem Outcomes Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Post-traumatic Osteoarthritis; Surgery; Avascular Necrosis; Femoral Neck Fractures; Hip Osteoarthritis; Trochanteric Fractures
• Intervention / Treatment: Device: Insignia uncemented Hip Stem

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.

• Study Type: Interventional
• Enrollment (Actual): 313
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • The MORE Foundation
  • California
    • San Francisco, California, United States, 94158
      • University of California, San Francisco
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Midwest Orthopaedics at Rush
  • Nevada
    • Reno, Nevada, United States, 89503
      • Reno Orthopedic Center Foundation
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health: University Orthopaedic Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Alleghany Health Network- Research Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37204
      • TOA Research Foundation
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott and White Medical Center
  • Washington
    • Seattle, Washington, United States, 98122
      • Orthopedic Physician Associates
    • Spokane, Washington, United States, 99208
      • Providence Orthopedics and Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Insignia uncemented Hip Stem; 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; Device: Replacement of arthritic hip with Insignia uncemented Hip Stem

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Estimated): April 2, 2034
• Study Completion (Estimated): April 2, 2034

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Leg Injuries; Necrosis; Fractures, Bone; Osteoarthritis; Femoral Fractures; Hip Injuries; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Hip Fractures; Osteoarthritis, Hip; Femoral Neck Fractures; Osteonecrosis
• Other Study ID Numbers: 107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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