CoNNECT: Conduit Nerve approximation versus Neurorraphy Evaluation of Clinical outcome Trial. This trial is based at the Birmingham Hand Centre, University Hospitals NHS Foundation Trust. The study is led by Chief Investigator Dominic Power and opened in July 2017. The study is assessing the outcome of suture less nerve repair after injury. A transected nerve is traditionally repaired using multiple small microsurgical sutures. The manipulation of the nerve and the uneven tension across the nerve ends that results may impede nerve regeneration. This study is designed to avoid suture repair using nerve conduits as connectors to provide a tension free environment at the injury site. The CoNNECT is the largest UK study of peripheral nerve injury. 240 nerves will be repaired and the final results will be available in 2021. The trial is adopted to the NIHR portfolio and is supported through a commercial grant from POLYGANICS

RANGER is a registry study of AVANCE processed nerve allograft in the management of nerve gaps. The study is run in conjunction with AxoGen Inc. a USA based leading biomedical technology company in the field of nerve injury and repair. The study collects utility, safety and efficacy data on the use of allograft and contributes to the emerging evidence base for the use of this technology in peripheral nerve surgery. Dominic Power is the Chief Investigator for the UK. The University Hospitals Birmingham NHS Foundation Trust was the first centre from outside North America to be asked to contribute data to this important study. The RANGER data has provided valuable information to the National Institute for Health and Care Excellence (NICE) in the UK. NICE has provided guidance on the use of AVANCEâ processed nerve allograft in UK patients. The interventional procedure guidance is available via the link below. Further information for patients is available in the pdf. This information has been developed by thenervesurgeon in consultation with patients.

The Protect NEURO trial is an international multicentre trial evaluating the Neurocap^â (POLYGANICS, Netherlands) in the management of end neuromas. Neuromas are painful swellings in nerves following injury, resection or amputation. The study commenced in April 2017 and recruited 73 patients in 21 international centres of excellence in peripheral nerve surgery. Dominic Power was the Principle Investigator for the UK and was the leading recruitment centre with 34 neuromas treated in 22 patients at UHB. The study is closed to recruitment and final results will be available in Summer 2020. Preliminary results at 12 months demonstrate a significant reduction in neuropathic pain following neuroma treatment with decreased opiate use amongst trial participants.

WRAP: Wrapping of nerves in Revision surgery for the Alleviation of Pain.

Scarred nerves cause pain, tethering and impaired function. The WRAP study is examining the effects of protecting nerves with a collagen barrier membrane after release of scar tissue to prevent recurrence of scar around the nerve. The AxoGuard^â nerve protector is a porcine layered submucosal extracellular matrix that provides a barrier to scar. The layer rapidly revascularizes to provide a gliding layer around previously scarred nerve. The study commenced recruitment in 2016 and follows all cases of revision nerve surgery referred for treatment by thenervesurgeon. The results in carpal tunnel and cubital tunnel revision surgery have been presented at the FESSH and IFSSH international specialist hand and nerve surgery congresses. Preliminary findings are published in the JMSR and demonstrate good relief of symptoms and no requirement for re-operation due to recurrent scar. For more information on the management of nerve pain and scarring following previous nerve decompression contact the Nerve Clinic

COMBInE: Core Outcomes in Brachial plexus Injury Evaluation.

Brachial plexus injuries are complex and may result in loss of movement and feeling in the upper limb. Many injuries are associated with severe debilitating neuropathic pain. Surgical reconstruction aims at restoration of movement. Clinical studies typically report the muscle strength using the British Medical Research Council (MRC) grading system. However, improvements in MRC grade do not necessarily correlate with functional gains for patients. Other measures of function and patient reported outcome measures (PROMs) may not be appropriate in this complex patient group. A review of the published literature has demonstrated numerous outcome measures reported without consensus. The COMBInE study is designed to achieve a core outcome dataset that is robust, valid, relevant, reliable and responsive in this complex patient group. The core dataset is determined following qualitative research with patients and with a Delphi review with contributors from the surgery, therapy and patient sub-populations.

SCOPING: A Series of Clinical Observational Parameters Indicative of Nerve regeneration.

Following a nerve injury, repair does not guarantee useful functional recovery. Neural regeneration is slow and therefore there is a delay prior to evaluation of quality of recovery. The recovery window is narrow and a failed recovery cannot necessarily be salvaged with revision surgery. The SCOPING study is designed to provide further information on recovery parameters that may predict the final outcome during the early phase of regeneration. Small nerve fibre sub types are unmyelinated and regenerate faster than their large fibre counterparts. Small fibres control autonomic function and slow pain. The study will look at a number of clinical parameters, the rate of recovery and final functional outcomes. Thermographic imaging is used to quantify the vasomotor recovery, sudomotor recovery is measured using a grading scale and early motor recovery through the muscle squeeze sign. The differential Tinel’s sign will be evaluated alongside the other measures to provide a quantitative evaluation of recovery through the repair site and beyond.

MAP: Motor Assessment Protocol.

Following injury to the C5 +/or C6 nerve roots there is paralysis of function in the shoulder +/or elbow. Surgical reconstruction with nerve transfers is the mainstay of treatment and provides a reliable method of functional restoration. The primary outcome measure reported is the British Medical Research Council (MRC) grade and there is inter- and intra-observer variability in reporting. There is poor correlation with functional scores and patient reported outcome measures (PROMs). The MAP study is reporting on the results of reconstruction in 40 patients and will provide insight into the patient perspective. Patients are assessed by two independent upper limb research physiotherapists following treatment in the West Midllands Brachial Plexus and Peripheral Nerve Injury Service. The study commenced in 2018 and will close in 2020.

I-HaND: Impact of Hand Nerve Disorders.

The I-HaND is a patient-reported outcome measure (PROM) that was developed by Mark Ashwood and Professor Christina Jerosch Herold at the University of East Anglia. Following development clinical evaluation was undertaken at several UK test centres. 
Caroline Miller, senior research Physiotherapist in the HaPPeN team collected datasets for validation through the West Midlands Brachial Plexus and Peripheral Nerve Injury Service. 
The PROM is designed specifically with nerve dysfunction at the core and evaluates impact on patients’ lives. The PROM is being further evaluated by the HaPPeN team for use in digital nerve repair outcome assessment for use in a future multi-centre UK study of digital nerve repair (Neon Study). Further validation in digit amputation, for the evaluation of post-amputation neuroma and in revision carpal tunnel syndrome is underway at the Birmingham Hand Centre.

MONTHS: Motor Nerve Transfer Histopathological Study.

Nerve transfer surgery involves transfer of a functioning fascicle from within an intact nerve or a named but expendable motor nerve branch to a non-functioning but more important motor branch to a paralysed muscle. Although nerve transfer was traditionally reserved for otherwise non-salvageable situations including nerve root avulsion of the brachial plexus, extension to other paralysing conditions, particularly those with incomplete denervation has raised the question of a possible extended window for successful reinnervation. The traditional 6-12 months critical period may not be as limiting as previously considered In the tetraplegic patient, successful reinnervation can be achieved many years after spinal cord injury as long as the target muscle has some upper motor neurone paralysis and is not fully denervated. MONTHS is a prospective histological and clinic correlation study that aims to compare donor and recipient axon counts at the time of nerve transfer with future motor and functional recovery.

Post-Amputation Incidence of Neuropathic Pain Pilot.

Following digit amputation there is a rate of symptomatic neuroma formation of approximately 6% with higher rates of 8.5% seen when the original injury had resulted in direct nerve trauma. Many more patient have protracted recovery due to stump sensitivity, contact allodynia and phantom pain. The natural course of recovery is poorly understood and hand therapy has a valuable role to play in reintegration of the hand to normal daily activity. The diagnosis of a neuroma is not standardised. Interventions for neuromas are varied and poorly reported in the literature. The HaPPeN team is working with a biomedical technology company to develop and evaluate a novel neuroma prevention intervaention at the time of primary amputation. The PAIN-P2 is a study designed to evaluate the recovery in post-amputation patients and will validate a novel PROM in this group. An algorithm for neuroma diagnosis will be tested in this patient population that will form a contemporaneous cohort study for a Phase 1 intervention study to be delivered in 2020.