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

December 20, 2010
November 26, 2012
December 2010
November 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01265004 on ClinicalTrials.gov Archive Site
Functional outcome [ Time Frame: 6 month ] [ Designated as safety issue: No ]
After 6 month the functinal outcome is measured by clinical scores.
Same as current
Not Provided
Not Provided
 
Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon
Evaluation of Microcirculation in Skin and Tendon After Surgical Treatment of Acute Rupture of the Achilles Tendon With Stitches or Fibrin-glue

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with acute traumatic rupture of the achilles tendon

  • Microcirculation
  • Achilles Tendon Rupture
  • Procedure: Stitches
    Surgical treatment of a rupture of the achilles tendon, in which both end are fastened with a U-forming stitching
  • Procedure: Fibrin-glue
    Surgical treatment, in which both ends are glued together using a medical fibrin-containing 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
  • 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.
    Intervention: Procedure: Stitches
  • Fibrin-glue, rupture of achilles tendon
    Patients, who received a surgical treatment including a fixing of the tendon with fibrin-glue.
    Intervention: Procedure: Fibrin-glue
  • Stiches and Fibrin-glue
    Patients, in who the achilles rupture was treated with stitches and fibrin-glue.
    Intervention: Procedure: Stitches and Fibrin-glue
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01265004
CTC-A10-26
No
RWTH Aachen University
RWTH Aachen University
Not Provided
Study Chair: Hans-Christoph Pape, Univ-prof.MD Chief of medicine
RWTH Aachen University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP