Profemur L Revision Study
Research type
Research Study
Full title
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
IRAS ID
168387
Contact name
Wiebe Postma
Contact email
Sponsor organisation
Microport Orthopedics Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 11 months, 27 days
Research summary
This study aims to follow the longevity of previously implanted revision total hip implants ( the primary or first implant has already been replaced prior to study start)in 30 patients for up to 10 years after implantation. The study also seeks to measure the study subjects' hip functionality (standard of care) and quality of life.
The primary purpose of this study is to provide data to the notified body (regulatory) as part of the requirement for renewal of the CE mark.Lay Summary of Results:
MicroPort Orthopedics (MPO), a US based medical device company started this clinical trial with Mr. Bartlett in 2016. This trial collected safety and performance data on a medical device that is used to treat hip arthritis, where the previous surgical treatments/ implantations have failed (Primary of first implant needs to be replaced). The medical device is called Profemur L Revision femoral stem. Patients with severe arthritis of the hip were surgical implanted with this device to replace their natural hip, in an attempt to help them regain their daily functioning.
There were 25 patients who joined this study from 2016-2018. These patients were implanted with this device and followed up at (2-5) years, (5-7) years and 10 years post-surgery. The study ended in May 2023. During the course of the study, none of the participants had any medical problems related to the device or the surgical procedure. Out of 25 participants, 18 were followed up for 10 years, while the rest were either lost to follow up (5) or died due to unrelated reasons (2).
The performance of the device was analyzed by asking participants to answer two questionnaires about their hip function and overall quality of life with the implanted device. After 10 years of being implanted with the device, most participants experienced only mild to moderate hip arthritis and were satisfied with their quality of life.
Outcomes of this study has enabled MPO to determine that this device is safe for treating patients with severe hip arthritis, which in turn can help them lead a good quality life with normal hip function.REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/0455
Date of REC Opinion
1 May 2015
REC opinion
Further Information Favourable Opinion