Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon
NCT ID: NCT01265004
Last Updated: 2012-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2010-12-31
2012-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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.
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Hans-Christoph Pape, Univ-prof.MD
Role: STUDY_CHAIR
Chief of medicine
Locations
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Universal Hospital of the RWTH Aachen University
Aachen, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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CTC-A10-26
Identifier Type: -
Identifier Source: org_study_id