Insignia™ Hip Stem Outcomes Study

Not Applicable

Active, not recruiting

• Conditions: Femoral Neck Fractures; Trochanteric Fractures; Rheumatoid Arthritis; Hip Osteoarthritis; Avascular Necrosis; Post-traumatic Osteoarthritis; Surgery
• Interventions: Device: Insignia uncemented Hip Stem

• Registration Number: NCT05144191
• Lead Sponsor: Stryker Orthopaedics

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.

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-03
• Study Start: 2022-02-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2034-04-02
• Study Completion: 2034-04-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 313

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insignia uncemented Hip Stem	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.

Primary Outcome Measures

Name	Time	Method
Survival Rate	10 years	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)	10 Years	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

Name	Time	Method
Harris Hip Score (HHS)	pre-op, 6 week, 1,2,5 and 7 years	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 - Visual analogue scale (VAS)	pre-op, 6 week, 1,2,3, 4,5,7 and 10 years	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	2 years	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%.
EQ-5D - Descriptive System	pre-op, 6 week, 1,2,3, 4,5,7 and 10 years	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.

Trial Locations

Locations (11)

Northwell Health: University Orthopaedic Associates; 🇺🇸 Great Neck, New York, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Orthopedic Physician Associates; 🇺🇸 Seattle, Washington, United States

Baylor Scott and White Medical Center; 🇺🇸 Temple, Texas, United States

Midwest Orthopaedics at Rush; 🇺🇸 Chicago, Illinois, United States

Alleghany Health Network- Research Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Providence Orthopedics and Sports Medicine; 🇺🇸 Spokane, Washington, United States

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States

Reno Orthopedic Center Foundation; 🇺🇸 Reno, Nevada, United States

The MORE Foundation; 🇺🇸 Phoenix, Arizona, United States

TOA Research Foundation; 🇺🇸 Nashville, Tennessee, United States