跳至主要内容
临床试验/NCT03931486
NCT03931486已完成不适用

Detection of Bacterial DNA and Collagen Metabolism in Acutely Ruptured Achilles Tendons

Copenhagen University Hospital, Hvidovre1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Heavy water (D2O) enrichment in acutely ruptured Achilles tendons

研究概览

简要总结

The etiology and pathogenesis of acute Achilles tendon ruptures are complex and not fully understood. It is well known that they are associated with pre-existing pathological alterations, similar to the changes observed in tendinopathy.

The present study investigates if bacteria and collagen metabolism play a role in the etiology of acute Achilles tendon rupture. During surgery, 20 patients will have taken two biopsies from the ruptured part of the tendon and two biopsies from the healthy tissue of the same tendon 2-4 cm proximal to the rupture, as a control.

详细描述

Objectives

  1. To investigate the collagen turnover in Achilles tendons prior to a rupture.
  2. To investigate the relative collagen turnover in Achilles tendons the days immediately after a rupture.
  3. To investigate the acute collagen protein synthesis rate in acutely ruptured Achilles tendons.
  4. To investigate if bacterial DNA is present in samples from the degenerative tissue in acutely ruptured Achilles tendons compared with samples from the healthy tissue of the ruptured tendon.

Background

Tendon ruptures are severe injuries that potentially lead to reduced function, reduced activity and sick leave. In younger, sports active individuals with strong tendons, an acute traumatic event is usually needed to trigger a rupture. With age the tendons are exposed to degenerative changes and can therefore rupture in everyday activities (spontaneously).

The etiology and pathogenesis of spontaneous tendon ruptures are complex and not fully understood. It is well known that they are associated with pre-existing pathological alterations, similar to the changes ob-served in tendinopathy. Recently, Dakin et al. found that ruptured Achilles tendons show evidence of chronic (non-resolving) inflammation. The condition might be a result of collagenolytic injury followed by failed tendon healing. Yet, other theories are still highly debated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-70 years
  • Appointment in the Outpatients Department within 4 days after injury.
  • Total Acute Achilles tendon rupture
  • The patient must be able to speak and understand Danish.
  • The patient must be able to give informed consent.

排除标准

  • Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
  • Previous rupture of the same Achilles tendon
  • Undergone any surgery in the same region as the affected Achilles tendon.
  • In medical treatment of diabetes.
  • Present infection in the affected region.
  • Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
  • Inability to lie in prone position on the operating table.
  • Rheumatoid arthritis or any other inflammatory disorder of the joints.
  • Terminal illness or severe medical illness. ASA score higher than or equal to 3.

结局指标

主要结局

Heavy water (D2O) enrichment in acutely ruptured Achilles tendons

时间窗: The outcome measure will be assesed at time of surgery

2H isotope enrichment in the biopsies from the ruptured part of the tendons and in the control biopsies proximal to the rupture.

14C concentration in acutely ruptured Achilles tendons

时间窗: The outcome measure will be assesed at time of surgery

14C concentration in biopsies from the ruptured part of the tendons and in the control biopsies proximal to the rupture are compared to the known historical values of atmospheric 14C to estimate the rate of collagen turnover. The values for turnover in the biopsies will be compared to the known rates of turnover in healthy tendons.

Fractional synthesis rate of protein at time of surgery in acutely ruptured Achilles tendons.

时间窗: The outcome measure will be assesed at time of surgery

The enrichment of the 15N marked proline tracer measured in the biopsies from the ruptured part of the tendons and in the control biopsies and compared to the enrichment of 15N marked proline in the blood. Based on that, the fractional synthesis rate of protein at the time of surgery is calculated.

Presence of bacteria in acutely ruptured Achilles tendons.

时间窗: The outcome measure will be assesed at time of surgery

Presence of bacterial DNA in the biopsies from the ruptured part of the tendons and in the control biopsies proximal to the rupture detected by 16s rDNA PCR

次要结局

未报告次要终点

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Allan Cramer

Principal Investigator

Copenhagen University Hospital, Hvidovre

研究点 (1)

Loading locations...

相似试验