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

Sponsor

RWTH Aachen University (Other)

Overall Status

Completed

CT.gov ID

NCT01265004

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microcirculation Achilles Tendon Rupture	Procedure: Stitches Procedure: Fibrin-glue Procedure: Stitches and Fibrin-glue

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Functional outcome [6 month]
After 6 month the functinal outcome is measured by clinical scores.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universal Hospital of the RWTH Aachen University	Aachen	NRW	Germany	52074

Sponsors and Collaborators

RWTH Aachen University

Investigators

Study Chair: Hans-Christoph Pape, Univ-prof.MD, Chief of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

RWTH Aachen University

ClinicalTrials.gov Identifier:

NCT01265004

Other Study ID Numbers:

CTC-A10-26

First Posted:

Dec 22, 2010

Last Update Posted:

Nov 27, 2012

Last Verified:

Nov 1, 2012

Keywords provided by RWTH Aachen University

Functional outcome

Additional relevant MeSH terms:

Rupture

Fibrin Tissue Adhesive

Study Results

No Results Posted as of Nov 27, 2012