Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon

Microcirculation Clinical Trial

— MicroASR  

Official title:

Evaluation of Microcirculation in Skin and Tendon After Surgical Treatment of Acute Rupture of the Achilles Tendon With Stitches or Fibrin-glue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265004
• Other study ID #: CTC-A10-26
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: November 26, 2012
• Start date: December 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Microcirculation
• Rupture

Intervention

Procedure:
• Stitches
Surgical treatment of a rupture of the achilles tendon, in which both end are fastened with a U-forming stitching
• Fibrin-glue
Surgical treatment, in which both ends are glued together using a medical fibrin-containing glue
• 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

Locations

Country	Name	City	State
Germany	Universal Hospital of the RWTH Aachen University	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Functional outcome	After 6 month the functinal outcome is measured by clinical scores.	6 month	No