Comparison of clinically used bilayer collagen membrane and trilayer collagen prototype fixation stability in chondral defects at the talus - An experimental human specimen study.
Bilayer collagen membrane
Chondral lesion
Fibrin glue
Talus
Trilayer collagen prototype
Journal
Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons
ISSN: 1460-9584
Titre abrégé: Foot Ankle Surg
Pays: France
ID NLM: 9609647
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
31
10
2019
revised:
02
01
2020
accepted:
27
01
2020
pubmed:
12
2
2020
medline:
11
5
2021
entrez:
12
2
2020
Statut:
ppublish
Résumé
The purpose of this human specimen experimental study was to compare the fixation stability of clinically used bilayer collagen membrane with fibrin glue with trilayer collagen prototype without fibrin glue in chondral defects at the medial or lateral talar shoulder (both matrices from Geistlich Pharma AG, Wollhusen, Switzerland). Eleven human specimens were used. The membranes were implanted in standardized chondral defects at the medial and lateral talar shoulder randomized. All tests were performed in load-control 15 kg. Range of motion ROM of each ankle was examined individually before testing. The average ROM was 10° dorsiflexion range 0°-20° and 30° plantarflexion range 20°-45°. 1,000 testing cycles with the defined ROM were performed. Two independent investigators, blinded to membrane and fixation type, visually assessed the membrane fixation integrity for peripheral detachment, area of defect uncovered, membrane constitution and delamination. The clinically used bilayer collagen membrane plus fibrin glue showed higher fixation stability than the trilayer prototype (all p < 0.05). No significant differences occurred between medial and lateral talar shoulder location (all p > 0.05). The fixation stability of the trilayer collagen prototype without fibrin glue is lower than of the clinically used bilayer membrane with fibrin glue in chondral defects at the medial and lateral talar shoulder in an experimental human specimen test. Clinical use of trilayer collagen prototype without fibrin glue has to be validated by clinical testing to evaluate if the lower stability of fixation is still sufficient.
Sections du résumé
BACKGROUND
BACKGROUND
The purpose of this human specimen experimental study was to compare the fixation stability of clinically used bilayer collagen membrane with fibrin glue with trilayer collagen prototype without fibrin glue in chondral defects at the medial or lateral talar shoulder (both matrices from Geistlich Pharma AG, Wollhusen, Switzerland).
METHODS
METHODS
Eleven human specimens were used. The membranes were implanted in standardized chondral defects at the medial and lateral talar shoulder randomized. All tests were performed in load-control 15 kg. Range of motion ROM of each ankle was examined individually before testing. The average ROM was 10° dorsiflexion range 0°-20° and 30° plantarflexion range 20°-45°. 1,000 testing cycles with the defined ROM were performed. Two independent investigators, blinded to membrane and fixation type, visually assessed the membrane fixation integrity for peripheral detachment, area of defect uncovered, membrane constitution and delamination.
RESULTS
RESULTS
The clinically used bilayer collagen membrane plus fibrin glue showed higher fixation stability than the trilayer prototype (all p < 0.05). No significant differences occurred between medial and lateral talar shoulder location (all p > 0.05).
CONCLUSIONS
CONCLUSIONS
The fixation stability of the trilayer collagen prototype without fibrin glue is lower than of the clinically used bilayer membrane with fibrin glue in chondral defects at the medial and lateral talar shoulder in an experimental human specimen test. Clinical use of trilayer collagen prototype without fibrin glue has to be validated by clinical testing to evaluate if the lower stability of fixation is still sufficient.
Identifiants
pubmed: 32044174
pii: S1268-7731(20)30027-8
doi: 10.1016/j.fas.2020.01.007
pii:
doi:
Substances chimiques
Fibrin Tissue Adhesive
0
Collagen
9007-34-5
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
35-39Informations de copyright
Copyright © 2020. Published by Elsevier Ltd.