Studies closed to recruitment

Protect NEURO

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Protect NEURO is an international commercially funded multi-centre trial sponsored by POLYGANICS BV, Netherlands. The study is evaluating intermediate term results of the Neurocap TM in the management of and symptomatic neuromas. Recruitment closed in July 2018 and the final results will be available autumn 2020

CaT-PINCH

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CaT-Pinch is a study completed with the SyMon Lab at the University of Birmingham testing subtle changes in grip perception in patients with carpal tunnel syndrome versus control. The study will  establish whether carpal tunnel release improves grip feedback control and the correlation with disease severity

MAP

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MAP: Motor Assessment after Brachial Plexus Injury

This trial is a rehabilitation outcome assessment trial evaluating motor recovery and PROM scores for patients treated with nerve transfer reconstruction for upper brachial plexus injury

I-HaND Validation

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EPIC

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EPIC: Electronic Patient Information Collaboration was a preliminary study evaluating utility, acceptability and retention of electronic patient information provision in the post-operative care and hand therapy management of patients treated for flexor tendon injury at the Birmingham Hand Centre

Want an update on a HaPPeN trial?

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Register your interest through the "contact us" link at the bottom of the page and the HaPPen team will add you to their mailing list and share the monthly HaPPeN newsletter updates. Alternatively follow the HaPPeN team on social media using the links below.

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Protect neuro

Protect NEURO Study

Protect NEURO is a multi-centre international interventional cohort study evaluating the Neurocap (Polyganics BV, Netherlands) in the management of end neuromas. 


Neuromas are painful nerve endings following trauma or amputation that result in severe neuropathic pain and functional impairment. There is no consensus on the optimum management of neuromas, however encapsulation has demonstrated benefit with capping devices, although compromised by late mechanical irritation. 


The Neurocap TM is made from a polylactide of polycaprolactone bioresorbable polymer that softens over 12 weeks and is fully resorbed by 18 months. The Neurocap TM provides a temporary mechanical barrier to scar tethering of the nerve stump following surgical implantation  after neuroma resection. The cap prevents mechanical irritation of the nerve, reducing fibrosis and pain. The chamber allows some unsupported axon outgrowth from the transected nerve stump which eventually involutes due to the absence of mechanical or neurotropic stimulation. 


The success of the pilot STOP Neuro study led to roll out of this international commercially sponsored trial. Dominic Power was asked to be the Principle Investigator for the UK and the HaPPeN team is the world leading recruitment centre with 34 neurocap implantations in 22 of 73 recruited patients across 23 international centres of excellence in peripheral nerve surgery.


The trial results will be available by August 2020 and the 12 months follow-up data are to be presented at the American Society for Surgery of the Hand in September 2019.

Learn More

The Neurocap is a bioresorbable capping device for protecting nerve ends following neuroma excision. The trial has closed to recruitment but follow-up is ongoing. Final results will be available in 2020. Dominic Power is the Principle Investigator for UHB and the UK.

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CaT-PINCH

CaT-PINCH: Carpal Tunnel Pinch grip responsiveness study

The CaT-PINCH  study was developed with Professor Allan Wing in the SyMon Lab in the School of Psychology, Birmingham University. Dominic Power was the Principle Investigator at UHB for the HaPPeN team and the clinical component of the study was performed by Tom Pidgeon, as part of an Academic Foundation Training Post in the West Midlands Deanery. 


The controls were recruited and tested at Birmingham University by Diar Karim, a doctoral research scientist in the SyMon Lab. Patients were recruited with suspected carpal tunnel syndrome and their disease severity was established using clinical scores, symptom severity scores and neurophysiological grading. 

Patients were recruited to a one-stop carpal tunnel clinic at the Birmingham Hand Centre, providing clinical assessment, neurophysiology and treatment. Trial recruitment was from this clinic setting.


Patients were tested for grip responsiveness to perturbation using a validated test protocol. Following surgical decompression, patients were re-tested to establish whether the test protocol can correlate with disease severity and predict patients response to surgery. The study has closed to recruitment.


The preliminary results were presented at the British Orthopaedic association meeting in Liverpool in 2017. The final results of CaT-PINCH will be available in 2019.

Learn More

CaT-PINCH was a study undertaken by Tom Pidgeon as a part of his 

Academic Foundation Training Fellowship with the HaPPeN team at UHB.

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MAP

MAP: Motor Assessment after Plexus injury

The Motor Assessment protocol after brachial Plexus injury study was conceived by Caroline Miller, the Chief Investigator and Physiotherapy Research lead at HaPPeN. Dominic Power advised on study design and is the PI.


The outcomes from brachial plexus reconstruction are ........

Learn More

MAP  assess outcomes after BPI and defines whether motor strength and endurance correlates with functional improvement. To find out more contact Caroline Miller.

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I-HaND: Impact of Hand Nerve Disorders

I-HaND PROM validation study

The I-HaND is a patient reported outcome measure (PRTOM) 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.

Learn More

The I-HaND is a PROM designed to measure functional impairment and response to intervention for patients with conditions affecting hand nerve function. For more information on the I-HaND or other outcomes assessment after nerve injury, contact Caroline Miller or Suzanne Beale at HaPPeN.

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EPIC

EPIC: Electronic Patient Information Communication

The EPIC pilot study was registered with C-Arms at UHB as a preliminary investigation to evaluate utility, acceptability and retention of digital information provision versus printed information sheets for patients following a flexor tendon repair within the hand at the Birmingham Hand Centre.


A DVD and electronic information including patient’s surgery and therapy following flexor tendon repair to include:


• Explanation of anatomy

• Description of surgery

• Description of Splint and therapy

• Precautions following surgery

• Advice on function and return to work


Background:

Patients have access to a wide range of digital media for information gathering.  98% of people living in the UK aged less than 40 years of age using the internet daily. A high incidence of traumatic hand injuries occur in 79-86% of the population less than 40 years of age and for this reason we proposed that digital information would be a useful tool in patient education and information provision.


The published literature reports that 50% of patients following flexor tendon rehabilitation want more information than is currently provided and that successful outcomes following surgery depend on adherence with post-operative therapy regimens. The design of the study was to develop and evaluate improved digital media for informing to patients about their flexor tendon injury and recovery.


Methods:

The audit was completed in two cycles with both groups containing 10 flexor tendon repairs. Patients were selected consecutively as they presented for surgery following a flexor tendon injury to the hand.  

Group 1 were given standard patient information leaflet and verbal information at their first appointment.  At the second appointment they were given a quiz on retaining information.

Group 2 were shown the video post operatively whilst in recovery and again at their first therapy appointment.  At the second appointment they were given a questionnaire on the how useful they found the video.


Results:

  • All patients across both groups reported they would be either likely or extremely likely to recommend our service to friends and family.
  • All patients across both groups found the information relating totheir injury either useful or very useful.
  • All patients felt confident in managing their injury.
  • Only one patient felt they could have been given more information relating to theirinjury and this was from group 1, they reported wanting “more information on scar massage and time frames”.
  • When asked: “Is there anything else our service can do to improve your experience?” one person from group 1 reported “yes, to some extent” but failed to expand further.
  • Most patients felt that the video helped them understand their injury and were confident in managing their therapy.
  • Patients perception of what is important to them is retained when information is given to them in both written and audio/visual format, such as purpose of splint, length of time needed to wear the splint and therapy frequency.
  • Audio/visual delivery overall improved patients ability to retain more information.
  • 100% of patients felt they understood what a flexor does and why we need to protect their repair.


Conclusion:

It is evident from this audit that patient information is important in patient’s understanding of their injury, surgery and rehabilitation.  Future DVD’s have been produced on rehabilitation following injury/surgery mallet, central slip and extensor tendons.


Funding:

The EPIC study was funded by QEHB charities


Learn More

EPIC was a pilot prior to developing a portfolio of patient education digital resources. The project was supported by a pump-priming grant from UHB charities. The team are working on a number of other digital media patient education projects. Please get in touch if you would like to contribute, collaborate or support this activity.

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