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

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.

Study Overview

• Status: Completed
• Conditions: Achilles Tendon Rupture; Microcirculation
• Intervention / Treatment: Procedure: Stitches; Procedure: Fibrin-glue; Procedure: Stitches and 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Universal Hospital of the RWTH Aachen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute traumatic rupture of the achilles tendon

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microcirculation	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.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	After 6 month the functinal outcome is measured by clinical scores.	6 month

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Study Chair: Hans-Christoph Pape, Univ-prof.MD, Chief of medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (Estimate): December 22, 2010

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Functional outcome
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: CTC-A10-26