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

RWTH Aachen University

Status: Completed

Conditions: Achilles Tendon Rupture; Microcirculation

Treatments: Procedure: Fibrin-glue; Procedure: Stitches and Fibrin-glue; Procedure: Stitches

Study type: Observational

Funder types: Other

Identifiers

NCT01265004

CTC-A10-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 3 patient groups

Stitches, rupture of achilles tendon

Description:

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.

Treatment:

Procedure: Stitches

Fibrin-glue, rupture of achilles tendon

Description:

Patients, who received a surgical treatment including a fixing of the tendon with fibrin-glue.

Treatment:

Procedure: Fibrin-glue

Stiches and Fibrin-glue

Description:

Patients, in who the achilles rupture was treated with stitches and fibrin-glue.

Treatment:

Procedure: Stitches and Fibrin-glue