Synthetic Versus Autologous Reconstruction (Syn-VAR) of the MPFL
Research type
Research Study
Full title
Synthetic Versus Autologous Reconstruction (Syn-VAR) Study for Recurrent Patellar Instability : A Prospective Randomised Pilot Study
IRAS ID
211907
Contact name
JD Acton
Contact email
Sponsor organisation
Western Health & Social Care Trust
Duration of Study in the UK
1 years, 1 months, 29 days
Research summary
Recurrent patellar instability incidence is 5.8/100,000 population, and recurrent dislocations reports range form 15-80%. Recurrent instability is multifactorial in etiology and makes management challenging. A lack of a homogeneous population with robust clinical outcomes studies compounds this further. Surgical options include soft tissue reconstruction in the skeletally immature patient, with MPFL reconstruction in combination with Vastus Medius Obliquitus (VMO) advancement to optimise patellar alignment. The options for MPFL reconstruction include autologous hamstring graft reconstruction, or the use of a synthetic polyester woven grafts instead. In theory, in the young active patient, the surgeon may wish to preserve the hamstring tendons to reduce operative morbidity and also allow hamstring preservation in the longer term.
The primary aim is to directly compare post-operative outcomes in patients with recurrent instability of the patella treated either by hamstring (H) autograft reconstruction, or using a synthetic (S) graft.
Elligible patients aged 14-25 will be randomised to receive either H-MPFL or S-MPFL reconstruction by way of blind envelope randomisation. Envelopes will be randomised by a member of the Theatre team but not the immediate research team. Once randomised, the patients will have the procedure explained, and have the option to proceed, or cross over pre-operatively between autologous or synthetic fixation. A single centre single surgeon approach will be employed using a their surgical technique. Standard post-operative follow up will be performed with additional validated outcome scores assessment.
All data will be held on encrypted Western Trust computer devices, under password protection of the study authors involved. Records will be kept for 3 years after completion of the study to provide us with 5 year follow up data before being destroyed.REC name
HSC REC B
REC reference
17/NI/0129
Date of REC Opinion
21 Aug 2017
REC opinion
Further Information Favourable Opinion