MicrocirculationMicroASRNCT01265004
Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon
An observational study of Microcirculation and Achilles Tendon Rupture, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microcirculation, Achilles Tendon Rupture
- What is being tested?
- Stitches, Fibrin-glue and Stitches and Fibrin-glue
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute traumatic rupture of the achilles tendon
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universal Hospital of the RWTH Aachen University
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Evaluation of Microcirculation in Skin and Tendon After Surgical Treatment of Acute Rupture of the Achilles Tendon With Stitches or Fibrin-glue
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.
Read the 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.
- Conditions
- Microcirculation, Achilles Tendon Rupture
- Being tested
- Stitches, Fibrin-glue, Stitches and Fibrin-glue
- Keywords
- Functional outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StitchesProcedure or surgery
Surgical treatment of a rupture of the achilles tendon, in which both end are fastened with a U-forming stitching
Fibrin-glueProcedure or surgery
Surgical treatment, in which both ends are glued together using a medical fibrin-containing glue
Stitches and Fibrin-glueProcedure or surgery
Surgical treatment, in which both ends of the ruptured tendon are fastened together with u-forming stitches as well as fibrin-glue
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Stitches | |
| Fibrin-glue, rupture of achilles tendon | Patients, who received a surgical treatment including a fixing of the tendon with fibrin-glue. Receives: Procedure: Fibrin-glue | |
| Stiches and Fibrin-glue | Patients, in who the achilles rupture was treated with stitches and fibrin-glue. Receives: Procedure: Stitches and Fibrin-glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (1)
Functional outcome
After 6 month the functinal outcome is measured by clinical scores.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans-Christoph Pape, Univ-prof.MD, Study chair, Chief of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265004
- Sponsor's protocol ID
- CTC-A10-26
- Acronym
- MicroASR
- Status last verified
- Nov 2012
- First submitted
- 20 Dec 2010
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microcirculation in Skin and Tendon After Surgical Treatment of Acute Rupture of the Achilles Tendon With Stitches or Fibrin-glue
- ClinicalTrials.gov ID
- NCT01265004
- Acronym / sponsor ID
- MicroASR / CTC-A10-26
- Conditions
- Microcirculation, Achilles Tendon Rupture
- Keywords
- Functional outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stitches, rupture of achilles tendon | – | Procedure: StitchesPatients, 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. |
| Fibrin-glue, rupture of achilles tendon | – | Procedure: Fibrin-gluePatients, who received a surgical treatment including a fixing of the tendon with fibrin-glue. |
| Stiches and Fibrin-glue | – | Procedure: Stitches and Fibrin-gluePatients, in who the achilles rupture was treated with stitches and fibrin-glue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute traumatic rupture of the achilles tendon
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StitchesSurgical treatment of a rupture of the achilles tendon, in which both end are fastened with a U-forming stitching | Procedure or surgery | Stitches, rupture of achilles tendon |
| Fibrin-glueSurgical treatment, in which both ends are glued together using a medical fibrin-containing glue | Procedure or surgery | Fibrin-glue, rupture of achilles tendon |
| Stitches and Fibrin-glueSurgical treatment, in which both ends of the ruptured tendon are fastened together with u-forming stitches as well as fibrin-glue | Procedure or surgery | Stiches and Fibrin-glue |
Primary outcome
Microcirculation
Time frame: 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.
1 secondary outcome
Functional outcome
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Christoph Pape, Univ-prof.MD study chair
Chief of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcirculation and Achilles Tendon Rupture, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microcirculation (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.