Insignia™ Hip Stem Outcomes Study

NCT05144191 | Active Not Recruiting FDA Device

• 1 other identifier: 107
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Harris Hip Score (HHS)

  pre-op, 6 week, 1,2,5 and 7 years

• EQ-5D - Descriptive System

  pre-op, 6 week, 1,2,3, 4,5,7 and 10 years

• EQ-5D - Visual analogue scale (VAS)

  pre-op, 6 week, 1,2,3, 4,5,7 and 10 years

• Survival Rate

  2 years

Study Arms (1)

Insignia uncemented Hip Stem

OTHER

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

Interventions

Insignia uncemented Hip Stem DEVICE

Device: Replacement of arthritic hip with Insignia uncemented Hip Stem

Insignia uncemented Hip Stem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (11)

The MORE Foundation

Phoenix, Arizona, 85023, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

Location

Reno Orthopedic Center Foundation

Reno, Nevada, 89503, United States

Location

Northwell Health: University Orthopaedic Associates

Great Neck, New York, 11021, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Alleghany Health Network- Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

TOA Research Foundation

Nashville, Tennessee, 37204, United States

Location

Baylor Scott and White Medical Center

Temple, Texas, 76508, United States

Location

Orthopedic Physician Associates

Seattle, Washington, 98122, United States

Location

Providence Orthopedics and Sports Medicine

Spokane, Washington, 99208, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteonecrosis; Arthritis, Rheumatoid; Femoral Neck Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 3, 2021
• Study Start: February 7, 2022
• Primary Completion (Estimated): April 2, 2034
• Study Completion (Estimated): April 2, 2034
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)