PPK Clinical Outcomes Study, v1
Research type
Research Study
Full title
Persona Partial Knee Clinical Outcomes Study
IRAS ID
214066
Contact name
Nicholas J. London
Contact email
Sponsor organisation
Zimmer GmbH
Duration of Study in the UK
11 years, 0 months, 1 days
Research summary
This study is a prospective, post-market, global, multi-center, non-controlled, observational clinical evaluation of the commercially available Persona® Partial knee implant. The primary objective of the study is to obtain survivorship data and assess clinical performance (outcomes) using outcome measurement tools (e.g. patient questionnaires), radiographic assessments and adverse event data. \n\nIn total, there will be 30 global sites in the US and Europe. In the UK, the multi-center study is being conducted at four sites in England with a maximum of 40 patients at each center. \n\nMale and female individuals aged 18 years and over, with a confirmed diagnosis of osteoarthritis and who qualify for unicompartmental (partial) knee surgery will be potentially eligible to take part. Each Investigator will offer study participation to each consecutive eligible patient who satisfies the Inclusion/Exclusion criteria for partial knee arthroplasty using the commercially available Partial Persona Knee. \n\nFollowing completion of the informed consent process, participants will undergo preoperative clinical evaluations prior to their partial knee arthroplasty. Patients will then be asked to attend post-operative follow-up clinic visits at 3 months, 1 year, 2 year, 5 year and 10 year. At these follow-up visits, clinical and radiographic evaluations will be conducted.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0327
Date of REC Opinion
9 Dec 2016
REC opinion
Further Information Favourable Opinion