NCT03672929

Allofit® IT With HXPE in Total Hip Arthroplasty

Allofit® IT With HXPE in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 197 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study design is a multi-center, prospective, non-controlled, consecutive cohort postmarket clinical follow-up study to obtain survival and outcome data on the Allofit IT Shell in combination with Longevity Liners in primary total hip arthroplasty.

Detailed description

The study will involve orthopedic surgeons skilled in total hip arthroplasty and experienced with the implants subject of this study. In total, 5 centers will be involved. This number of clinical sites will permit assessment of the consistency among a multitude of Investigators. A total number of 200 subjects will be included in the study. It is anticipated that each clinical site will enroll 40-60 eligible study subjects, who have provided written informed consent. Ethics Committee (EC) approval for each site has to be obtained prior to conducting this research. Sequentially, all eligible patients will be offered study enrollment at each center to avoid potential selection bias. All potential subjects will be required to participate in an informed consent process and sign an EC approved written informed consent prior to study enrollment. It is anticipated the enrollment period may be 12 months or longer to assure an adequate number of cases at each site. Each case enrolled will receive an Allofit IT HXPE Bearing System. The study is designed to be prospective to ensure that the study population is representative of the type of population that the device is intended to treat. The subjects included will be candidates for All subjects will undergo preoperative clinical, functional and radiographic evaluations, total hip arthroplasty, immediate post-operative evaluations and post-operative clinical, functional and radiographic evaluations at 6 months (± 1 month), 1 year (± 2 months), 2 year (± 2 months), 3 year (± 2 months), 5 year (± 2 months), 7 year (± 2 months), and 10 year (± 2 months).

Conditions

• Avascular Necrosis
• Osteoarthritis, Hip
• Inflammatory Arthritis
• Post-Traumatic Osteoarthritis of Hip

Timeline

• Start date: 2011-06-05
• Primary completion: 2025-07-03
• Completion: 2025-07-03
• First posted: 2018-09-17
• Last updated: 2026-01-27
• Results posted: 2026-01-27

Locations

5 sites across 4 countries: Austria, France, Germany, Spain