Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon (MicroASR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01265004
First received: December 20, 2010
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.


Condition Intervention
Microcirculation
Achilles Tendon Rupture
Procedure: Stitches
Procedure: Fibrin-glue
Procedure: Stitches and Fibrin-glue

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Microcirculation in Skin and Tendon After Surgical Treatment of Acute Rupture of the Achilles Tendon With Stitches or Fibrin-glue

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Microcirculation [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    The microcirculation is measured by O2c, an non-invalive device functioning with lightwaves. Based on this data the soft tissue damage, edema and healing process is protocoled.


Secondary Outcome Measures:
  • Functional outcome [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    After 6 month the functinal outcome is measured by clinical scores.


Enrollment: 20
Study Start Date: December 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Stitches, rupture of achilles tendon
Patients, in who the achilles tendon rupture was treated with tendon surgery including a special way of stitching to preserve the sliding ability of the tendon.
Procedure: Stitches
Surgical treatment of a rupture of the achilles tendon, in which both end are fastened with a U-forming stitching
Fibrin-glue, rupture of achilles tendon
Patients, who received a surgical treatment including a fixing of the tendon with fibrin-glue.
Procedure: Fibrin-glue
Surgical treatment, in which both ends are glued together using a medical fibrin-containing glue
Stiches and Fibrin-glue
Patients, in who the achilles rupture was treated with stitches and fibrin-glue.
Procedure: Stitches and Fibrin-glue
Surgical treatment, in which both ends of the ruptured tendon are fastened together with u-forming stitches as well as fibrin-glue

Detailed Description:

This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.

Every method is long established and can be treated as clinical equal. So the surgical treatment is chosen randomly for each patient.

For this cause the microcirculation is registered by O2c, which works with measuring reflected lightwaves. It is strictly noninvasive and causes absolutely no pain for the patient. The measurement device consists of two small probes, which simply stick to the patient´s skin. There are nine measurements on this study: one before and one shortly after the surgery, followed by three measuring appointment every 6 hours (6,12,18,24 h post-op).Afterwards there are appointments planed after 12 days and 6 month. On the last appointment the patients are questioned according to established scores like AOFAS or VAS to register the functional outcome and level of pain.

Clinical parameters like time between rupture and surgical treatment, hospitalisation time, and form of anaesthesia are included to create comparable patient profiles. After 6 moths the last measurement appointment is stated, in which the clinical outcome is registered by Scores, e.g Mann-Whitney-Wilcoxon-Test.

This study is to detect any difference in wound heeling, re-rupture rate and functionality between these three methods.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acute traumatic rupture of the achilles tendon

Criteria

Inclusion Criteria:

  • Acute rupture of the achilles tendon (on one or both sides)
  • Older than 18 year of age
  • Firmed letter of approval
  • Patient speaks/understands German
  • Planed surgical treatment
  • No more than 48h after rupture

Exclusion Criteria:

  • No-traumatic rupture of the achilles tendon
  • More than 48h after rupture
  • No planed surgical treatment
  • History of surgery on the injured leg
  • Condition of diabetes mellitus
  • Condition of peripheral artery occlusive disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265004

Locations
Germany
Universal Hospital of the RWTH Aachen University
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Chair: Hans-Christoph Pape, Univ-prof.MD Chief of medicine
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01265004     History of Changes
Other Study ID Numbers: CTC-A10-26
Study First Received: December 20, 2010
Last Updated: November 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
Functional outcome

Additional relevant MeSH terms:
Rupture
Wounds and Injuries
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014