REMATCH study
Research type
Research Study
Full title
Removal of Metalwork following High Tibial Osteotomy – A Randomised Controlled Trial comparing Removal of Metalwork rates for the ActiveMotion (Newclip) and Tomofix (Synthes) High Tibial Osteotomy plates
IRAS ID
211393
Contact name
James Murray
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This study aims to compare two different plates currently used in high tibial osteotomy (HTO) surgery (knee realignment). The purpose of the metal osteotomy plates is to maintain the correct realignment achieved at surgery whilst the bone heals.
The TomoFix and ActivMotion plating systems are both used in current practice and comply safety regulations.
Once the correction has healed (approx. 12 months) the plate can be left in. Some patients may however experience discomfort that related to the plate and benefit from plate removal , about a year after their initial operation. The ActivMotion plate design is a smaller than the Tomofix and it is therefore potentially less likely to cause discomfort . It is anticipated that second operations for plate removal will be less frequent than for the Tomofix plate.
A small cohort study (Tomes et al. Unpublished data) suggested that plate removal rates may be much lower – 5%. However there has been no comparative study. In this study we would like to compare the number of plates that need removal following surgery, assess pain levels in patients in the first two years following surgery and compare the amount of analgesia used in the immediate post operative recovery period.
Patients who will be asked to participate are those about to have a high tibial osteotomy. Participants will beasked to complete a questionnaire before they have their operation and twelve months after the operation to assess their pain and function. They will also be asked to record their pain levels before their operation, for 5 days after their operation and at each of their routine follow ups ( 2&6 weeks and 12 months). The amount of analgesia participants use will be recorded in the initial post operative period. This information will be used to compare the outcome of the plates.REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0896
Date of REC Opinion
26 Jul 2017
REC opinion
Further Information Favourable Opinion