Clinical trial NCT01265004: Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microcirculation
Achilles Tendon Rupture
Keywords: Functional outcome
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute traumatic rupture of the achilles tendon

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microcirculation
timeFrame: 6 month
Secondary outcomes:
measure: Functional outcome
timeFrame: 6 month
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universal Hospital of the RWTH Aachen University
state: NRW
Study officials:
affiliation: Chief of medicine
name: Hans-Christoph Pape, Univ-prof.MD
role: STUDY_CHAIR
References: