Achilles Tendon Rupture, Microcirculation
Conditions
Keywords
Functional outcome
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.
Interventions
PROCEDUREStitches
Surgical treatment of a rupture of the achilles tendon, in which both end are fastened with a U-forming stitching
PROCEDUREFibrin-glue
Surgical treatment, in which both ends are glued together using a medical fibrin-containing glue
PROCEDUREStitches 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
Sponsors
RWTH Aachen University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome | 6 month | After 6 month the functinal outcome is measured by clinical scores. |
Countries
Germany
Outcome results
None listed