Early PROMPT Study
Research type
Research Study
Full title
A Longitudinal study investigating whether Patient Reported Outcome Measures at day of discharge and 3-weeks Post Total Knee Arthroplasty (TKA) predict outcomes at 12-months post-operatively?
IRAS ID
191464
Contact name
GARETH STEPHENS
Contact email
Sponsor organisation
The Royal Orthopaedic Hospital NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Title: Early PROMPT Study
Background Approximately 20% of patients are not satisfied after Total knee replacement (Wylde et al, 2011). However, it remains a challenge to reliably identify the candidates who will do well and who will not following TKA (Lungu et al, 2014a). Studies which have looked at the predictive value of pre-operative factors have not been able to establish clear guidelines on this issue (Desmeules et al, 2013, Lungu et al 2014b, Wylde et al, 2007). Post-operatively, it appears the first 12-week period is a critical phase of recovery as pain, function and satisfaction studies have shown that persistent problems remaining at 12-weeks post-operatively are predictive of problems at 1 year (Mitsuyasu et al, 2011; Williams et al, 2013). Very few studies have analysed whether there are factors present in the first 6-weeks post op, which reliably predict long term outcomes. Logically, the earlier patients at risk of problems are identified, the more chance there is to provide interventions which reduce the negative impact of them (Williams et al, 2013).
Purpose: This study is aiming to identify whether variables at day of discharge and 3-weeks post TKA predict outcomes at 1 year post-operatively.
Methods: 200 patients will be consented at their pre-operative appointment and then seen on their day of discharge from Hospital following Primary Total Knee Arthroplasty to complete the Outcome Measures Booklet. They will be given an extra copy with to take home with them. At 3-weeks post-op; the patient will be phoned to remind them to return the booklet. At 12-months, the patient will be sent the booklet for a final time via the post with a SAE.
Outcomes: The main aim is to determine whether patient reported outcomes at day of discharge and 3-weeks post TKA predict outcomes at 12-months post-operatively.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0142
Date of REC Opinion
26 Feb 2016
REC opinion
Favourable Opinion