The Comprehensive Assessment in Children After Surgical T... | NCT03983213

Studies
The Comprehensive Assessment in Children After Surgical Treatment of Patellar Recurrent Dislocation.

NCT03983213

Sponsor

Polish Mother Memorial Hospital Research Institute

Status

Completed

Last Update Posted

Feb 12, 2021Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Recurrent Patellar Dislocation
Patellar Instability

Interventions

mpfl reconstruction

Countries

Poland

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

Sep 2020

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

May 28, 2019Actual

Primary Completion Date

Oct 30, 2020Actual

Completion Date

Nov 30, 2020Actual

First Submitted Date

Jun 10, 2019

First Submission Date that Met QC Criteria

Jun 10, 2019

First Posted Date

Jun 12, 2019Actual

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

Feb 9, 2021

Last Update Posted Date

Feb 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Detailed Description

Recurrent patellar dislocation occurs mostly in adolescents. Recently medial patellofemoral ligament reconstruction has become treatment of choice in most cases. There is still insufficient literature to assess the operative treatment results according to functional testing.

The aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for clinical assessment. Merchant and lateral X-ray pictures will be analysed for patellar position verification along with isokinetic and gait evaluation to produce conclusions referring to efficacy of the treatment. All subjects included in the study were treated with mpfl reconstruction with gracilis tendon harvesting. Follow-up provided is longer than 2 years in all 45 cases planned to enroll. All subject are to be mailed and invited to check-up visit including analysis of parameters mentioned above. Soon after data collection text of the publication will be made. The results will be discussed with recent literature and conclusions will be made.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pat. after mpfl reconstruction		All 45 subjects operated with mpfl reconstruction included to chek-up after follow-up.	Procedure: mpfl reconstruction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mpfl reconstruction	Procedure	Harvested gracilis tendon is pulled through patella and femur in anatomic position and locked with interference screw.	Pat. after mpfl reconstruction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dislocation recurrence	The incident of patellar dislocation after treatment	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age <18 yo
recurrent patellar dislocation
ready for follow-up

Exclusion Criteria:

age <18 yo
osteochondral fracture
habitual dislocation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

45 patients under 18 yo, 30 females, 15 males, average age of 15 yo

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kryspin Niedzielski, Ph.D.	Polish Mother Memorial Hospital Research Institute	Study Chair
Krzysztof Małecki, Ph.D.	Polish Mother Memorial Hospital Research Institute	Study Director
Jacek Beczkowski, M.D.	Polish Mother Memorial Hospital Research Institute	Principal Investigator
Paweł Flont, Ph. D.	Polish Mother Memorial Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Polish Mother Memorial Hospital Research Institute		Lodz		93-338	Poland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Sharing IPD after data collection in Exel

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

After data collection

Access Criteria

Not known yet

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D031222	Patellar Dislocation

Ancestor Terms

ID	Term
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided