Dataset Information

Biological Amnion Prevents Flexor Tendon Adhesion in Zone II: A Controlled, Multicentre Clinical Trial.

ABSTRACT:

Introduction

Tendon adhesion to surrounding tissues is the most common complication reported after tendon repair. To date, effective solutions to prevent tendon injury are still lacking.

Materials and methods

A total of 89 patients with flexor tendon injury in zone II were recruited. The patients were divided into a control group, a poly-DL-lactic acid (PDLLA) group, and an amnion group according to the different tendon treatments applied. The control group was not subjected to other treatments. PDLLA and bioamniotic membranes were, respectively, used to wrap broken ends in the PDLLA and amnion membrane groups. The patients were followed at 1, 2, 3, 6, and 12 months after surgery and the ranges of active flexion and extension lag in the proximal and distal interphalangeal joints were evaluated.

Results

The means of total active ranges of motion of the interphalangeal joints (excluding rupture cases) in the PDLLA and amnion groups did not significantly differ between each other but significantly differed from that of the control group. Statistical analysis showed a significant difference in the clinical grades of the outcomes among the control, PDLLA, and amnion groups. The incidence of complications in the control and PDLLA groups was found to be significantly higher than that in the amniotic membrane group; no significant difference was observed between the control and PDLLA groups.

Conclusion

In this study, freeze-dried amniotic membrane transplantation was applied to promote healing of the flexor tendon in zone II and prevent adhesion. This technique presents a new method to solve the issue of tendon adhesion after repair.

Clinical trial registration

The trial was registered by identifier ChiCTR1900021769.

SUBMITTER: Liu C

PROVIDER: S-EPMC6470416 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:The adhesion of tendon and surrounding tissue is the most common complication after repairing an injured tendon. The injured flexor tendons in zone II are frequently accompanied by tendon sheath defects, which lead to poor recovery. A variety of biological and non-biological materials have been recently used for repair or as substitute for tendon sheaths to prevent tendon adhesion. However, non-biological materials, such as polyethylene films, have been used to prevent tendon adhesions by mechanical isolation. The possibility of tendon necrosis and permanent foreign body remains due to the lack of permeability and the obstruction of nutrient infiltration. The natural macromolecule amniotic membrane derived from organisms is a semi-permeable membrane with the following characteristics: smooth; without vascular, nerve, and lymphatic; and rich in matrix, cytokines, enzymes, and other active ingredients. The unique structure of this membrane makes it an ideal biomaterial. In the experiment in Henry chicken, the model of tendon sheath defect and the flexor digitorum tendon in zone II was established and randomly divided into control group, medical membrane group, and decellularized amniotic membrane group. Samples were obtained at the 2nd, 4th, 8th, and 12th week after operation. General, histological, and biomechanical tests were performed to investigate the preventive effect of repaired tendon sheath by decallularized amniotic membrane. Experimental results showed the following: the amniotic membrane group and the medical membrane group had mild inflammatory reaction and tissue edema, and nearly no adhesion was observed in the surrounding tissue; the fibroblast-like cells were distributed in layers under the light microscope; the amniotic membrane group was denser than the medical membrane group cells, and numerous fibroblasts were disorganized in the control group. Biomechanical measurements showed that the sliding distance of tendon, the total flexion angle of the toes, and the tendon maximum tensile breaking strength at the early postoperative were significantly better than in the control group. Through this experiment, the amniotic membrane, as a natural biological substitute material in the construction of tendon sheath, can effectively inhibit exogenous healing and promote endogenous healing to prevent tendon adhesion.

Project description:BackgroundPeritendinous adhesion is the most common complication of tendon repairs in the hand and often requires surgical intervention, resulting in increased labor loss and increased treatment costs. Many agents used to reduce tendon adhesion in animal models, however these agents have not entered clinical use. This study is the first-ever clinical study that evaluates encircling tendon repair site with collagen sheet as an anti-adhesion barrier.MethodsBetween December 2014 and January 2020, 156 patients included in this study, with clean cut isolated flexor digitorum profundus (FDP) tendon injury in flexor tendon zone 2. All tendons repaired with modified double Kessler technique. In 76 patients, tendon repair site encircled with collagen sheet. 80 patients were randomly selected from our clinical records and functional results are compared with Strickland's total active motion grading system.ResultsThe mean total range of motion was 79% in the control group and 81% in the collagen sheet group, and there was no statistically significant difference between the two groups (Z: - 1.393, p = 0.164). In the control group, very good and good repair according to Strikland classification was 65/80 (81%). In the collagen sheet group, it was 62/76 (82%), respectively. There was statistically significant difference between 5 FDP TAM measurements between collagen sheet and control group (t(35) = 0.29, p = 0.016, p < 0.05). The mean TAM of the 5 FDP tendons in the collagen sheet group: 83.8 (SD: 8.2) in the and 76.1 (SD: 9.5) in the control group.ConclusionsFor the first time in the literature, functional results of Zone 2 flexor tendon repair using collagen sheets in patients with clean cut tendon injuries reported. However, there were no statistical difference about total active motion between control and collagen sheet group, 5th FDS tendon repairs encircled with collagen sheets had better outcomes. Prospective studies in patient groups with high adhesion risk are recommended.