NCT03589001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

July 3, 2018

Last Update Submit

July 1, 2019

Conditions

Osgood-Schlatter DiseaseApophysitis

Outcome Measures

Primary Outcomes (1)

  • Current knee pain

    Participants self-report if they still have knee pain

    24 months

Secondary Outcomes (9)

  • Pain intensity

    24 months

  • Pain frequency

    24 months

  • Duration of being pain-free

    24 months

  • Medical attention

    24 months

  • Use of pain killers

    24months

  • +4 more secondary outcomes

Study Arms (1)

OSD

51 adolescents with Osgood Schlatter who participated in an activity modification intervention.

Other: Activity modification

Interventions

Activity modificationOTHER

Activity modification, exercises and gradual return to sport

OSD

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Adolescents aged 10-14 years old diagnosed with Osgood Schlatter

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice in Aalborg

Aalborg, 9220 Ø, Denmark

Location

MeSH Terms

Conditions

Osteochondrosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post- Doctoral Research Fellow

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 17, 2018

Study Start

July 10, 2018

Primary Completion

December 1, 2018

Study Completion

February 28, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07

Locations

DK(1)