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

Completed

• Conditions: Microcirculation; Achilles Tendon Rupture
• Interventions: Procedure: Stitches and Fibrin-glue; Procedure: Stitches; Procedure: Fibrin-glue

• Registration Number: NCT01265004
• Lead Sponsor: RWTH Aachen University

Brief 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.

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-26
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stiches and Fibrin-glue	Stitches and Fibrin-glue	Patients, in who the achilles rupture was treated with stitches and fibrin-glue.
Stitches, rupture of achilles tendon	Stitches	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.
Fibrin-glue, rupture of achilles tendon	Fibrin-glue	Patients, who received a surgical treatment including a fixing of the tendon with fibrin-glue.

Primary Outcome Measures

Name	Time	Method
Microcirculation	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.

Secondary Outcome Measures

Name	Time	Method
Functional outcome	6 month	After 6 month the functinal outcome is measured by clinical scores.

Trial Locations

Locations (1)

Universal Hospital of the RWTH Aachen University; 🇩🇪 Aachen, NRW, Germany