Dataset Information

Clinical and biometrical 12-month follow-up in patients after reconstruction of the sural nerve biopsy defect by the collagen-based nerve guide Neuromaix.

ABSTRACT: Many new strategies for the reconstruction of peripheral nerve injuries have been explored for their effectiveness in supporting nerve regeneration. However only a few of these materials were actually clinically evaluated and approved for human use. This open, mono-center, non-randomized clinical study summarizes the 12-month follow-up of patients receiving reconstruction of the sural nerve biopsy defect by the collagen-based nerve guide Neuromaix. Neuromaix was implanted as a micro-structured, two-component scaffold bridging 20-40 mm nerve defects after sural nerve biopsy in twenty patients (eighteen evaluated, two lost in follow-up). Safety of the material was evaluated by clinical examination of wound healing. Performance was assessed by sensory testing of modalities, pain assessment, and palpation for the Hoffmann-Tinel's sign as well as demarcating the asensitive area at each follow-up visit. Every patient demonstrated uneventful wound healing during the complete 12-month time course of the study. Two patients reported complete return of sensation, whereas eleven out of eighteen patients reported a positive Hoffmann-Tinel's sign at the lower leg with simultaneous reduction of the asensitive area by 12 months. Our data show that Neuromaix can be implanted safely in humans to bridge sural nerve gaps. No procedure-related, adverse events, or severe adverse events were reported. These first clinical data on Neuromaix provide promising perspectives for the bridging of larger nerve gaps in combined nerves, which should be investigated more through extensive, multi-center clinical trials in the near future.

SUBMITTER: Bozkurt A

PROVIDER: S-EPMC5610476 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical and biometrical 12-month follow-up in patients after reconstruction of the sural nerve biopsy defect by the collagen-based nerve guide Neuromaix.

Bozkurt Ahmet A Claeys Kristl G KG Schrading Simone S Rödler Jana V JV Altinova Haktan H Schulz Jörg B JB Weis Joachim J Pallua Norbert N van Neerven Sabien G A SGA

European journal of medical research 20170922 1

Many new strategies for the reconstruction of peripheral nerve injuries have been explored for their effectiveness in supporting nerve regeneration. However only a few of these materials were actually clinically evaluated and approved for human use. This open, mono-center, non-randomized clinical study summarizes the 12-month follow-up of patients receiving reconstruction of the sural nerve biopsy defect by the collagen-based nerve guide Neuromaix. Neuromaix was implanted as a micro-structured, ...[more]

PMID: 28938917

Similar Datasets

Project description:Maturational changes in behavior, and the possible influence of the puppy-raising environment on behavioral development, were investigated in a total sample of 978 prospective guide dogs belonging to four different breeds/crosses. All dogs belonged to the same guide dog organization, and had been exposed to similar early environmental influences prior to being assigned to puppy-raising households at 7-8?weeks of age. Behavioral data were collected from puppy raisers when the dogs were 6 and 12?months old using the C-BARQ(©), a standardized, validated, and widely used survey instrument that measures the frequency and/or severity of most common behavior problems in dogs. Information about the puppy-raising environment was obtained from puppy raisers using a standardized questionnaire shortly before the dogs were returned to the guide dog organization for training. Data were analyzed using both univariate and multivariate statistics (binary logistic generalized estimating equations modeling and generalized linear modeling). The findings demonstrated specific maturational changes in behavior between 6 and 12?months of age. In particular, German Shepherd dogs displayed an increase in stranger-directed aggression compared with the other breeds/crosses between 6 and 12?months of age. Several aspects of the puppy-raising environment were associated with puppies' C-BARQ scores at 12?months of age. In particular, growing up in households with more experienced puppy raisers, and in the company of at least one other dog, were both associated with positive effects on a number of puppy behaviors. By contrast, puppies that had been frightened by a person or threatened by another unfamiliar dog showed significantly worse scores for fear of strangers and dogs, respectively. Being frightened by a person, being reared by less experienced puppy raisers, and/or in households without other pets were associated with less successful training outcomes. The relevance of these findings to current guide dog breeding and husbandry practices is discussed.

Dataset Information

Clinical and biometrical 12-month follow-up in patients after reconstruction of the sural nerve biopsy defect by the collagen-based nerve guide Neuromaix.

Publications

Clinical and biometrical 12-month follow-up in patients after reconstruction of the sural nerve biopsy defect by the collagen-based nerve guide Neuromaix.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets