24 Month Follow-up of Patients With Osgood Schlatter (OSD) | NCT03589001

Studies
24 Month Follow-up of Patients With Osgood Schlatter (OSD)

NCT03589001

Sponsor

Aalborg University

Status

Completed

Last Update Posted

Jul 2, 2019Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Osgood-Schlatter Disease
Apophysitis

Interventions

Activity modification

Countries

Denmark

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

Jul 2019

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

Jul 10, 2018Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Feb 28, 2019Actual

First Submitted Date

Jul 3, 2018

First Submission Date that Met QC Criteria

Jul 16, 2018

First Posted Date

Jul 17, 2018Actual

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

Jul 1, 2019

Last Update Posted Date

Jul 2, 2019Actual

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

Osgood Schlatter is a common knee condition, affecting approximately 10% of adolescents. OSD is thought to be a growth related pain conditon, and thus resolve after maturation. Despite this, there a lack of prospective data investigating whether this is in fact the case.

Detailed Description

This is a prospective cohort study of 51 adolescents (aged 10-14 at baseline) with Osgood schlatter. Participants are followed for two years.

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

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OSD		51 adolescents with Osgood Schlatter who participated in an activity modification intervention.	Other: Activity modification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Activity modification	Other	Activity modification, exercises and gradual return to sport	OSD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Current knee pain	Participants self-report if they still have knee pain	24 months

Secondary Outcomes

Measure	Description	Time Frame
Pain intensity	Worst pain in the previous week measured on a visual analogue scale (VAS) from 'no pain' to 'worst imaginable pain'	24 months
Pain frequency	Frequency of knee pain divided into (almost daily, several times per week, weekly, monthly, rarely, never)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

10-14 years of age
Pain at tibial tuberosity during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation
Pain during palpation of tibial tuberosity
Knee pain for 6 weeks or more

Exclusion Criteria:

Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).
Previous surgery
Pain from the hip or back that interferes with activities of daily living.
Habitual patella luxations
Clinical suspicion of meniscal lesion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Adolescents aged 10-14 years old diagnosed with Osgood Schlatter

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Unit for General Practice in Aalborg		Aalborg		9220 Ø	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD will be shared upon reasonable request, inline with Data Protection procedures

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055034	Osteochondrosis

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided