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

NCT03931486 | Completed

• 1 other identifier: H-18010363
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendon Rupture

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Operatively treated patients with Achilles tendon rupture

Cohort of operatively treated patients with acute Achilles tendon rupture.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with acute Achilles tendon rupture, seen in the outpatient clinic at Copenhagen University Hospital, Hvidovre.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

Department of Orthopedic Surgery, Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Cramer A, Hojfeldt G, Schjerling P, Agergaard J, van Hall G, Olsen J, Holmich P, Kjaer M, Barfod KW. Achilles Tendon Tissue Turnover Before and Immediately After an Acute Rupture. Am J Sports Med. 2023 Jul;51(9):2396-2403. doi: 10.1177/03635465231177890. Epub 2023 Jun 14.

  PMID: 37313851 DERIVED

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.

Study Officials

• Kristoffer W Barfod, MD

  Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 30, 2019
• Study Start: May 3, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

DK (1)