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

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ClinicalTrials.gov Identifier: NCT03931486
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Allan Cramer, Copenhagen University Hospital, Hvidovre

Brief 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.


Condition or disease
Achilles Tendon Rupture

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Detection of Bacterial DNA and Collagen Metabolism in Acutely Ruptured Achilles Tendons
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort
Operatively treated patients with Achilles tendon rupture
Cohort of operatively treated patients with acute Achilles tendon rupture.



Primary Outcome Measures :
  1. 14C concentration in acutely ruptured Achilles tendons [ Time Frame: 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.

  2. Heavy water (D2O) enrichment in acutely ruptured Achilles tendons [ Time Frame: 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.

  3. Fractional synthesis rate of protein at time of surgery in acutely ruptured Achilles tendons. [ Time Frame: 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.

  4. Presence of bacteria in acutely ruptured Achilles tendons. [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Biopsies from acutely ruptured Achilles tendonds will be taken, Two biopsies from the ruptured part of the tendon and two biopsies from the healthy tissue of the same tendon proximal to the rupture, as a control.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with acute Achilles tendon rupture, seen in the outpatient clinic at Copenhagen University Hospital, Hvidovre.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931486


Contacts
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Contact: Allan Cramer +4560174294 allancramer94@gmail.com

Locations
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Denmark
Department of Orthopedic Surgery, Copenhagen University Hospital, Hvidovre Recruiting
Hvidovre, Denmark, 2650
Contact: Kristoffer W Barfod, MD    +4561300288    kristoffer.barfod@regionh.dk   
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Bispebjerg Hospital
Investigators
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Study Chair: Kristoffer W Barfod, MD Copenhagen University Hospital, Hvidovre
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Responsible Party: Allan Cramer, Principal Investigator, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT03931486    
Other Study ID Numbers: H-18010363
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries