Insigniaâ„¢ Hip Stem Outcomes Study (NCT05144191) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Insigniaâ„¢ Hip Stem Outcomes Study
United States313 participantsStarted 2022-02-07
Plain-language summary
The objective of this study is to evaluate the safety and effectiveness of the Insigniaâ„¢ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
Who can participate
Age range18 Years
SexALL
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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 pertainin…