Minimal Invasive Treatment of Achilles Tendinopathy: Focu... | NCT04793971

Studies
Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)

NCT04793971

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Mar 11, 2021Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Tendinopathy

Interventions

percutaneous paratenon release

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Mar 23, 2015

First Submission Date that Met QC Criteria

Mar 8, 2021

First Posted Date

Mar 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2021

Last Update Posted Date

Mar 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
postoperative cases		patients that underwent percutaneous release of the paratenon for chronic midportion Achilles tendinopathy	Procedure: percutaneous paratenon release

Interventions

Name	Type	Description	Arm Group Labels	Other Names
percutaneous paratenon release	Procedure	percutaneous paratenon release for chronic midportion Achilles tendinopathy	postoperative cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VISA-A-score	specific questionnaire about (mal-)function of Achilles tendon	3 months

Secondary Outcomes

Measure	Description	Time Frame
SF-36-score	questionnaire about well-being	3 months
VAS-score	questionnaire about pain	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy

Exclusion Criteria:

insertional tendinopathy
open intervention
(partial) Achilles tendon rupture

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giovanni Matricali, MD, PhD	Foot and ankle surgeon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Leuven		Pellenberg	Vlaams-Brabant		Belgium

Condition Browse Module

MeSH Terms

ID	Term
D052256	Tendinopathy

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D013708	Tendon Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided