Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon (MicroASR)
|ClinicalTrials.gov Identifier: NCT01265004|
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : November 27, 2012
|Condition or disease||Intervention/treatment|
|Microcirculation Achilles Tendon Rupture||Procedure: Stitches Procedure: Fibrin-glue Procedure: Stitches and 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.
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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Evaluation of Microcirculation in Skin and Tendon After Surgical Treatment of Acute Rupture of the Achilles Tendon With Stitches or Fibrin-glue|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
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.
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.
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
- Microcirculation [ Time Frame: 6 month ]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.
- Functional outcome [ Time Frame: 6 month ]After 6 month the functinal outcome is measured by clinical scores.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265004
|Universal Hospital of the RWTH Aachen University|
|Aachen, NRW, Germany, 52074|
|Study Chair:||Hans-Christoph Pape, Univ-prof.MD||Chief of medicine|