TendinopathyNCT04793971
Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)
An observational study of Tendinopathy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
To evaluate the outcome of percutaneous paratenon release for chronic midportion Achilles tendinopathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tendinopathy
- What is being tested?
- percutaneous paratenon release
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Apr 2015
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy
Who may be able to join
- patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy
Who cannot join
- insertional tendinopathy
- open intervention
- (partial) Achilles tendon rupture
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the outcome of percutaneous paratenon release for chronic midportion Achilles tendinopathy.
Read the detailed description
Since 2011 the percutaneous procedure took the place of the open release of the paratenon for the surgical treatment for chronic midportion Achilles tendinopathy in the investigators' center. In this study the investigators re-evaluate the patients undergoing percutaneous surgery since then in order to compare the outcome with the excellent results cited in literature. The patients will be contacted and asked to participate completing a VAS-score, a VISA-A score and agreeing with a clinical examination.
Approving by the Ethical Committee of UZLeuven is pending.
- Conditions
- Tendinopathy
- Being tested
- percutaneous paratenon release
- Keywords
- chronic midportion Achilles tendinopathy, percutaneous paratenon release
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous paratenon releaseProcedure or surgery
percutaneous paratenon release for chronic midportion Achilles tendinopathy
| Study group | Role | What they receive |
|---|---|---|
| postoperative cases | patients that underwent percutaneous release of the paratenon for chronic midportion Achilles tendinopathy Receives: Procedure: percutaneous paratenon release |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISA-A-score
specific questionnaire about (mal-)function of Achilles tendon
Measured: 3 months
Secondary outcomes (2)
SF-36-score
questionnaire about well-being
Measured: 3 months
VAS-score
questionnaire about pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Matricali, MD, PhD, Principal investigator, Foot and ankle surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793971
- Sponsor's protocol ID
- S57392
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2015
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)
- ClinicalTrials.gov ID
- NCT04793971
- Acronym / sponsor ID
- S57392
- Conditions
- Tendinopathy
- Keywords
- chronic midportion Achilles tendinopathy, percutaneous paratenon release
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Mar 2021 (actual)
- 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.
To evaluate the outcome of percutaneous paratenon release for chronic midportion Achilles tendinopathy.
Detailed description
Since 2011 the percutaneous procedure took the place of the open release of the paratenon for the surgical treatment for chronic midportion Achilles tendinopathy in the investigators' center. In this study the investigators re-evaluate the patients undergoing percutaneous surgery since then in order to compare the outcome with the excellent results cited in literature. The patients will be contacted and asked to participate completing a VAS-score, a VISA-A score and agreeing with a clinical examination.
Approving by the Ethical Committee of UZLeuven is pending.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postoperative cases | – | Procedure: percutaneous paratenon releasepatients that underwent percutaneous release of the paratenon for chronic midportion Achilles tendinopathy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy
Key inclusion criteria (1 listed)
- patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy
Key exclusion criteria (3 listed)
- insertional tendinopathy
- open intervention
- (partial) Achilles tendon rupture
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 |
|---|---|---|
| percutaneous paratenon releasepercutaneous paratenon release for chronic midportion Achilles tendinopathy | Procedure or surgery | postoperative cases |
Primary outcome
VISA-A-score
Time frame: 3 months
specific questionnaire about (mal-)function of Achilles tendon
2 secondary outcomes
SF-36-score
Time frame: 3 months
VAS-score
Time frame: 3 months
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 11 Mar 2021.
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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.
Giovanni Matricali, MD, PhD principal investigator
Foot and ankle surgeon
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 Tendinopathy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 3 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 11 Mar 2021. 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 Belgium. 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?
VISA-A-score (time frame: 3 months). 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 11 Mar 2021.