Insignia™ Hip Stem Outcomes Study

Stryker

Status: Active, not recruiting

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

Treatments: Device: Insignia uncemented Hip Stem

Study type: Interventional

Funder types: Industry

Identifiers

NCT05144191

107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 313 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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313 participants in 1 patient group

Insignia uncemented Hip Stem

Other group

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.

Treatment:

Device: Insignia uncemented Hip Stem