NCT03312088

Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship

A Prospective, Multi-center, Single Arm Adaptive-design Study to Evaluate the Survivorship of the Maxx Orthopedics' PCK System in Revision Cases

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Maxx Orthopedics Inc · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.

Detailed description

The clinical investigation is designed to be prospective to ensure that the population is representative of the type of population for which the Freedom Total Knee® System with the revision components is intended to treat. Subjects with a primary diagnosis of end-stage symptomatic revision knee who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a revision total knee arthroplasty, by the Investigator, will be invited to take part in this clinical investigation. Patients will be drawn from hospital clinics focusing on this type of treatment. The treatment period of 36 months is considered sufficient to monitor the safety and clinical performance of the device. However, the patients will be contacted annually for 10 years or as long as the patient is willing to monitor their long-term progress. An interim report will be issued when at least 120 patients will complete the 12-month follow-up. No treatments will be withheld as part of this clinical investigation although any other treatments that need to be administered during the clinical investigation will be recorded.

Conditions

• Aseptic Loosening
• Infection
• Bone Loss
• MCL - Medial Collateral Ligament Rupture of the Knee
• Periprosthetic Fractures

Interventions

Type	Name	Description
DEVICE	Freedom Knee PCK Components	Total Knee Revision

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-01-01
• Completion: 2022-02-01
• First posted: 2017-10-17
• Last updated: 2021-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study