Study of the Insignia Hip Stem in Cementless Total Hip Replacement Surgery to Evaluate Implant Survival and Patient Outcomes

What this Trial Is About

Researchers are assessing the survivorship and patient-reported outcomes after implantation of the Insignia hip stem in people undergoing cementless total hip replacement surgery. The study compares this new hip stem to currently available stems used for the same procedure, aiming to evaluate if the 2-year implant survivorship of the Insignia stem is not worse than the benchmark for similar devices. The trial focuses on patients with arthritis conditions such as osteoarthritis, degenerative joint disease, and rheumatoid arthritis. All participants will receive the Insignia hip stem prosthesis during their cementless total hip arthroplasty surgery. This surgery typically lasts about two hours and is performed by experienced orthopedic surgeons trained in this procedure. The study is conducted at multiple centers before the device is widely marketed. Data collection includes follow-up over two years to monitor implant survival and patient health outcomes. Participants will be involved in assessments before surgery and at 6 months, 12 months, and 2 years after surgery. These assessments include various hip function scores, pain scales, quality of life questionnaires, and monitoring for complications such as stem loosening or femoral fractures. Mortality rates at 1 and 2 years post-surgery will also be recorded. The study includes close monitoring for any adverse events related to the implant during the follow-up period.

A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.