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

NCT01265004 | Completed

• 1 other identifier: CTC-A10-26
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Microcirculation; Achilles Tendon Rupture

Keywords

Functional outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional outcome

  6 month

Study Arms (3)

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

Fibrin-glue, rupture of achilles tendon

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

Procedure: Fibrin-glue

Stiches and Fibrin-glue

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

Procedure: Stitches and Fibrin-glue

Interventions

Stitches PROCEDURE

Surgical treatment of a rupture of the achilles tendon, in which both end are fastened with a U-forming stitching

Stitches, rupture of achilles tendon

Fibrin-glue PROCEDURE

Surgical treatment, in which both ends are glued together using a medical fibrin-containing glue

Fibrin-glue, rupture of achilles tendon

Stitches and Fibrin-glue PROCEDURE

Surgical treatment, in which both ends of the ruptured tendon are fastened together with u-forming stitches as well as fibrin-glue

Stiches and Fibrin-glue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute traumatic rupture of the achilles tendon

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Universal Hospital of the RWTH Aachen University

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Interventions

Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Hans-Christoph Pape, Univ-prof.MD

  Chief of medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 22, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

DE (1)