RECRUITING STUDIES

The CoNNECT study is an investigator led study developed by the HaPPeN team and run in conjunction with the Surgical Reconstruction and Microbiology Research Centre in the Institute of Translational Medicine at UHB. The trial is supported by a commercial grant from POLYGANICS BV, Netherlands, a biomedical device company that has developed the Neurolac TM bioresorbable polymer nerve conduit. 

The surgical techniques are recorded and presented using the OrthOracle education platform and the technical guides are used to deliver training workshops in trial methodology for surgeons recruiting patients to the study.

The trial has three arms and will evaluate whether addition of a conduit around a microsurgical neurorraphy confers a functional advantage and whether a suture less repair technique reduces complications including repair-site neuroma in continuity formation. 240 nerves are to be recruited over three years at the Birmingham Hand Centre. 90 patients have enrolled in the study in Q1 2019 and the interim 6 month data analysis will be be presented at the IFSSH meeting in Berlin in June  2019. 

The EHands EPR system at the Birmingham Hand Centre provides valuable information on patient recruitment, epidemiology and injury patterns. The 18 month recruitment data has been published in the Journal of Musculoskeletal Surgery and Research in January 2019. 

RANGER: Registry of Avance Nerve Graft Evaluating Utilization and Outcomes for the Reconstruction of Peripheral Nerve Discontinuities

The RANGER Study is a multi-centre international registry study evaluating the utility, safety and efficacy of the AVANCE TM processed nerve allograft in the management of nerve gaps. The registry opened in the USA in 2018 and there are 21 centres actively recruiting to the study dataset. Dominic Power is the chief investigator for the UK and site Principle Investigator for the Birmingham Hand Centre and the West Midlands Brachial Plexus and Peripheral Nerve Injury Service at UHB. The HaPPeN team are the first centre outside North America to join the study and are contributing their experience of the AVANCE to the 1600 nerve reconstructions collected to date.

AxoGen Inc., Alachua, Florida, is a biomedical company specialising in the management of peripheral nerve disorders. The AVANCE TM processed nerve allograft is a nerve graft substitute derived from human nerve tissue that can be used to bridge nerve gaps. The structure provides endometrial tubes with removal of neurological-inhibitory proteins. The AVANCE TM can be used as a substitute for autologous nerve graft to eliminate the donor site morbidity associated with harvest of the patient's own nerves.

The HaPPeN team receive funding to assist in collection of utilisation and efficacy data for the use of AVANCE TM processed nerve allograft at UHB.

The Match study is a cohort control arm within the RANGER study. The Birmingham Hand Centre and the West Midlands Brachial Plexus and Peripheral Nerve Injury Service jones the Match study in July 2018.

The study is evaluating utilisation and efficacy of autologous nerve grafts in gap management after peripheral nerve injury. 

Injury patterns, trauma severity, delay to reconstruction, method of reconstruction and distance to re-innervation are just some of the many variables influencing outcome from nerve injury. The variables are an impediment to recruiting to small cohort studies or multi-centre RCTs and as such the RANGER registry provides an opportunity for large scale data collection with sufficient powering to allow sub-group analyses.

The HaPPeN team are grateful to the sponsor AxoGen Inc. for allowing the UK to join this USA based study and pool experience in peripheral nerve reconstruction for the benefit of patients. 

The HaPPeN team receive funding support from AxoGen for delivery of anonymised utilisation and efficacy data, allowing the clinical team to collect standardised outcomes in a robust and more consistent way that enables comparison with published data in this field.