A prospective evaluation of 1st MPJ arthrodesis using MOXFQ & SF-12
Research type
Research Study
Full title
A prospective evaluation of clinical and radiographic outcome of patients undergoing first metatarsophalangeal joint arthrodesis using the Manchester Oxford Foot Questionnaire (MOXFQ) and Short Form 12 (SF-12).
IRAS ID
163107
Contact name
Paul Beeson
Contact email
Sponsor organisation
The University of Northampton
Duration of Study in the UK
2 years, 0 months, 5 days
Research summary
A prospective evaluation of clinical and radiographic outcome of patients undergoing 1st metatarsophalangeal joint (big toe) arthrodesis (fusion) using the Manchester Oxford Foot Questionnaire (MOXFQ) and Short Form 12 (SF-12).
The purpose of this study is to prospectively evaluate the clinical and radiographic outcome of patients undergoing 1st metatarsophalangeal joint (MTPJ) arthrodesis using a standardized operative technique (inter-fragmentary screw across spherical surfaces combined with dorsal plate as described by Aslam & Ribbans, 2005) and use the Manchester Oxford Foot Questionnaire (MOXFQ) and Short Form 12(SF-12) as primary outcome measures. It is considered that inclusion of these two validated measurement tools would provide originality and a novel approach to evaluation of 1st MTPJ arthrodesis.
The study will involve recruitment of participants with clinically confirmed 1st MTPJ pathology, resulting in pain and limitation of movement, who require an arthrodesis (<50% residual metatarsal head cartilage precludes cheilectomy). Participants will be recruited from Northampton General Hospital orthopaedic foot & ankle clinic by the clinical care team, under guidance of the Consultant and if necessary outside the NHS (Three Shires Hospital).
In addition to primary outcome measures (MOXFQ & SF-12) a descriptive analysis of the sample characteristics will be undertaken and secondary outcome measures (i.e. radiological, complications, patient satisfaction) will be evaluated. These provide additional relevant clinical information to further characterize the sample and enable comparison with other studies.
First MPJ arthritis and pain can lead to significant disability and morbidity that increases in severity over time. The economic burden that results consists of direct costs (NHS healthcare) and indirect costs (productivity i.e. temporary work lost due to absenteeism/disability). The level of disability also has the potential to increase the predisposition of affected individuals to associated co-morbidities (World Health Organization, 2009; Finkelstein et al, 2009; NICE guidance on hypertension, 2011; Segal et al, 1998). These may be substantial and so a successful surgical outcome is important in saving valuable NHS resources. Evidence suggests that 1st MTPJ arthrodesis can significantly improve quality of life with regard to disability, functioning and pain (Gibson & Thompson, 2005).
Primary research question
Is there a difference in the MOXFQ and SF-12 scores between baseline (pre-op) and at 6 and 12 months post-op following 1st MTPJ arthrodesis?Secondary research questions
These aim to determine:
1) What is functional capacity outcome at 6 & 12 months post-operatively?
2) What is patient satisfaction post-operatively?
3) How do 1st MTPJ and general foot pain duration, intensity and analgesic requirements change post-operatively?
4) How do the radiological parameters change post-operatively?
5) What are the post-operative complications & their timing?REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1203
Date of REC Opinion
12 Nov 2014
REC opinion
Further Information Favourable Opinion