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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03931486
Other study ID # H-18010363
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2019
Est. completion date April 1, 2021

Study information

Verified date July 2021
Source Copenhagen University Hospital, Hvidovre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Department of Orthopedic Surgery, Copenhagen University Hospital, Hvidovre Hvidovre

Sponsors (2)

Lead Sponsor Collaborator
Copenhagen University Hospital, Hvidovre Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 14C concentration in acutely ruptured Achilles tendons 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. The outcome measure will be assesed at time of surgery
Primary Heavy water (D2O) enrichment in acutely ruptured Achilles tendons 2H isotope enrichment in the biopsies from the ruptured part of the tendons and in the control biopsies proximal to the rupture. The outcome measure will be assesed at time of surgery
Primary Fractional synthesis rate of protein at time of surgery in acutely ruptured Achilles tendons. 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. The outcome measure will be assesed at time of surgery
Primary Presence of bacteria in acutely ruptured Achilles tendons. 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 The outcome measure will be assesed at time of surgery
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