Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date July 3, 2018
First Posted Date July 17, 2018
Last Update Posted Date July 2, 2019
Actual Study Start Date July 10, 2018
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2018)
Current knee pain [ Time Frame: 24 months ]
Participants self-report if they still have knee pain
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2018)
  • 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'
  • Pain frequency [ Time Frame: 24 months ]
    Frequency of knee pain divided into (almost daily, several times per week, weekly, monthly, rarely, never)
  • 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
  • Medical attention [ Time Frame: 24 months ]
    Participants will be asked to report if they sought medical attention outside of the intervention
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 24 Month Follow-up of Patients With Osgood Schlatter (OSD)
Official Title A Prospective Investigation of Osgood Schlatter With 24 Month Follow-up
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adolescents aged 10-14 years old diagnosed with Osgood Schlatter
Condition
  • Osgood-Schlatter Disease
  • Apophysitis
Intervention Other: Activity modification
Activity modification, exercises and gradual return to sport
Study Groups/Cohorts OSD
51 adolescents with Osgood Schlatter who participated in an activity modification intervention.
Intervention: Other: Activity modification
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 16, 2018)
51
Original Estimated Enrollment Same as current
Actual Study Completion Date February 28, 2019
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 14 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03589001
Other Study ID Numbers N-20140100-5
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: IPD will be shared upon reasonable request, inline with Data Protection procedures
Responsible Party Sinead Holden, Aalborg University
Study Sponsor Aalborg University
Collaborators Not Provided
Investigators Not Provided
PRS Account Aalborg University
Verification Date July 2019