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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589001
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Sinead Holden, Aalborg University

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.

Condition or disease Intervention/treatment
Osgood-Schlatter Disease Apophysitis Other: Activity modification

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.

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Investigation of Osgood Schlatter With 24 Month Follow-up
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : February 28, 2019

Group/Cohort Intervention/treatment
OSD
51 adolescents with Osgood Schlatter who participated in an activity modification intervention.
Other: Activity modification
Activity modification, exercises and gradual return to sport




Primary Outcome Measures :
  1. Current knee pain [ Time Frame: 24 months ]
    Participants self-report if they still have knee pain


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 24 months ]
    Worst pain in the previous week measured on a visual analogue scale (VAS) from 'no pain' to 'worst imaginable pain'

  2. Pain frequency [ Time Frame: 24 months ]
    Frequency of knee pain divided into (almost daily, several times per week, weekly, monthly, rarely, never)

  3. Duration of being pain-free [ Time Frame: 24 months ]
    Those who no longer have knee pain will be asked how long since their knee pain resoved

  4. Medical attention [ Time Frame: 24 months ]
    Participants will be asked to report if they sought medical attention outside of the intervention

  5. Use of pain killers [ Time Frame: 24months ]
    Participants will be asked if they use painkillers to manage their knee pain (y/n). If yes, they will be asked how often.

  6. knee injury and osteoarthritis outcomes score (KOOS) sport and activity subscale [ Time Frame: 24 months ]
    knee injury and osteoarthritis outcomes score (KOOS) subscale sport and activity. Minimum 0 points, maximum 100points, with 100 points being the best possible score.

  7. Sports participation [ Time Frame: 24 months ]
    Participants will report if they participate in sport. If yes how often and how much/week. They will also report if they have reduced sports participation due to knee pain.

  8. Health Related quality of life [ Time Frame: 24 months ]
    Health related quality of life assessed by EQ 5D 3L Y (EuroQol, 5 dimensions, 3 levels for youth). Minimum 0, maximum 1, with higher values indicating higher quality of life.

  9. Sleep [ Time Frame: 24 months ]
    Participants will be asked if they find it hard to sleep because of their knee pain (not at all, some nights, most nights).



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescents aged 10-14 years old diagnosed with Osgood Schlatter
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589001


Locations
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Denmark
Research Unit for General Practice in Aalborg
Aalborg, Denmark, 9220 Ø
Sponsors and Collaborators
Aalborg University
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Responsible Party: Sinead Holden, Post- Doctoral Research Fellow, Aalborg University
ClinicalTrials.gov Identifier: NCT03589001    
Other Study ID Numbers: N-20140100-5
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be shared upon reasonable request, inline with Data Protection procedures

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteochondrosis
Bone Diseases
Musculoskeletal Diseases