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NCT05144191 | Recruiting | Hip Osteoarthritis

Insignia™ Hip Stem Outcomes Study
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.

Condition or disease

Hip Osteoarthritis

Avascular Necrosis

Rheumatoid Arthritis

Post-traumatic Osteoarthritis

Femoral Neck Fractures

Trochanteric Fractures

Surgery

Intervention/treatment

Insignia uncemented Hip Stem

Phase

Not Applicable

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
Estimated Enrollment : 313 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : February 7, 2022
Estimated Primary Completion Date : December 31, 2033
Estimated Study Completion Date : December 31, 2034
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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Insignia™ Hip Stem Outcomes Study

Location Details

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Insignia™ Hip Stem Outcomes Study

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Nevada

Reno Orthopedic Center Foundation

Reno, Nevada, United States, 89503

Recruiting

United States, Washington

Toomey Orthopedic Research Institute, PLLC

Seattle, Washington, United States, 98122