Follow-up investigation into BMD changes in TKR patients version 1
Research type
Research Study
Full title
An investigation of the long-term effects on function and bone mineral density (BMD) post total knee replacement (TKR)in a female postmenopausal population - a follow-up study.
IRAS ID
237505
Contact name
Michael Gundry
Contact email
Sponsor organisation
University of Exeter
Duration of Study in the UK
1 years, 7 months, 21 days
Research summary
This study is designed as a follow-up of "Disuse osteopenia: The short and long-term effects of post-traumatic and post-surgical immobilisation following lower limb injury or total knee replacement “ (IRAS ID 36783), which was a study investigating the long term changes (over 12 months) on bone mineral density (BMD) following total knee replacement (TKR) patients, compared with a healthy control group. This follow up study will specifically be looking at changes in BMD at the bilateral hips, lumbar spine, bilateral knees, and total body to investigate if BMD loss in TKR is consistent with natural BMD loss after a 5 – 8 year period.
This study is being carried out as research has shown that TKRs are associated with low bone density, as such a low BMD score can result in a higher chance of fractures and thus the long term post intervention impact of TKR on BMD should be investigated further.
The study will involve contacting the 74 participants (28 TKR and 46 control) from the original study and performing a Dual X-ray Absorptiometry (DXA) scan at lumbar spine, both hips, both knees (side and front views), and total body, these measurements will then be compared to the research data already recorded.
The study will be completed in one visit at the University of Exeter Medical School facility. Following the consenting procedure participant height and weight will be recorded and a range of questionnaires relating to functionality, quality of life, depression and anxiety states will be administered prior to the DXA scans being performed.
Furthermore, 30 of the participants will receive a repeat set of DXA scans. This will produce comparable positional data with any difference in BMD between the scans due to positional error. This positional precision data will be applied to the statistical analysis of the study.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0020
Date of REC Opinion
4 Mar 2019
REC opinion
Unfavourable Opinion