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

Treatment of the Osgood Schlatter (OSGOOD)

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: NCT02824172
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

The disease Osgood-Schlatter is most commonly found in sports teenager growing up apophysose accounting for 28.4% of osteochondrosis by Breck. It relates to 62% of osteochondrosis knee and affects adolescent girls between 10 and 12 and boys between 12 and 15 It is usually considered a benign pathology that cures in the majority of cases. However, in 5-10% of cases there is persistent residual pain in adulthood.

The classic complication is the avulsion fracture of the tibial tuberosity in adolescents who continued his sports without restriction.

The possible consequences are numerous including the presence of a free bone fragment at the insertion of the tendon originally described by Osgood the establishment of a genu recurvatum, a high kneecap or patella alta and an enlarged tibial tuberosity (ATT) annoying sport.

The main two treatments are complete rest from sport activity or cast immobilization.

The main objective is to compare these two technics according to the proportion of full sporting recovering at 12 months


Condition or disease Intervention/treatment Phase
Osgood Schlatter Disease Other: cast immobilization group Other: complete sport rest. Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Cast immobilization
36 patients in the experimental cast immobilization
Other: cast immobilization group
Patients in this group will have their knee locked with a resin going from the ankle to the top of the thigh for 4 weeks, followed by 4 weeks without cast but with rehabilitation through physiotherapy.

Active Comparator: complete sport rest
36 patients in the complete sport rest group
Other: complete sport rest.
Patients included in this group will follow the current standard procedure for this disease that is to say complete sport rest during 8 weeks including rehabilitation through physiotherapy, following the exact same technic as the experimental group .




Primary Outcome Measures :
  1. Restarting a sporting activity [ Time Frame: 12 weeks after intervention ]
    Comparison between the 2 groups of the proportion of patient returning to sports activity 12 weeks after treatment.


Secondary Outcome Measures :
  1. Anterior tibial tuberosity pain [ Time Frame: Inclusion visit Day 0 ]
    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation

  2. Anterior tibial tuberosity pain [ Time Frame: follow-up visit week 4 ]
    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation

  3. Anterior tibial tuberosity pain [ Time Frame: follow-up visit week 8 ]
    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation

  4. Anterior tibial tuberosity pain [ Time Frame: follow-up visit week 12 ]
    Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation

  5. Pain killer consumption [ Time Frame: follow-up visit week 4 ]
    Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups

  6. Pain killer consumption [ Time Frame: follow-up visit week 8 ]
    Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups

  7. Quality of life assessment [ Time Frame: inclusion visit Day 0 ]
    Quality of life will be assessed using the SF-12 auto questionnaire

  8. Quality of life assessment [ Time Frame: follow-up visit week 12 ]
    Quality of life will be assessed using the SF-12 auto questionnaire

  9. Quality of life assessment [ Time Frame: follow-up visit month 6 ]
    Quality of life will be assessed using the SF-12 auto questionnaire. As the standard follow-up visit are over, this questionnaire will be asked by phone

  10. Activity level assessment [ Time Frame: inclusion visit Day 0 ]
    Activity level will be assessed using the Tegner scale

  11. Activity level assessment [ Time Frame: follow-up visit week 12 ]
    Activity level will be assessed using the Tegner scale

  12. Activity level assessment [ Time Frame: follow-up visit month 6 ]
    Activity level will be assessed using the Tegner scale. As the standard follow-up visit are over, this scale will be asked by phone

  13. complete sport rest compliance assessment [ Time Frame: follow-up visit week 4 ]
    The complete sport rest compliance will be assessed using a visual analogic scale (0 to 10, 0 will be a complete rest compliance)

  14. painfulness due to immobilization cast [ Time Frame: follow-up visit week 12 ]
    The patient in the cast immobilization group will be asked what was the level his/her level of cast tolerance: bad, average, good or very good.

  15. Quadricipital shortness [ Time Frame: inclusion visit Day 0 ]
    The Quadricipital shortness will be evaluated thanks to the knee flexion angle will be measured using the modified Thomas test as well as hamstring muscles length measured using the popliteal angle

  16. Quadricipital shortness [ Time Frame: follow-up visit week 4 ]
    The Quadricipital shortness will be evaluated thanks to the knee flexion angle will be measured using the modified Thomas test as well as hamstring muscles length measured using the popliteal angle

  17. Quadricipital shortness [ Time Frame: follow-up visit week 8 ]
    The Quadricipital shortness will be evaluated thanks to the knee flexion angle will be measured using the modified Thomas test as well as hamstring muscles length measured using the popliteal angle

  18. Patella size [ Time Frame: inclusion visit Day 0 ]
    The patella size will be measure on the lateral radiograph using the Caton and Deschamp index

  19. Patella size [ Time Frame: follow-up visit week 8 ]
    The patella size will be measure on the lateral radiograph using the Caton and Deschamp index

  20. Radiographic evolution of Osgood Schlatter disease [ Time Frame: follow-up visit week 12 ]
    Both clinicians and radiologist will evaluate separately the evolution of Osgood Schlatter disease using a new classification. It is based on 3 parameters: anterior tibial tuberosity fragmentation, thickening of soft tissues and presence or not of an ossicle.

  21. Potential return to sport activity [ Time Frame: follow visit week 8 ]
    After a week of training, patients of each group will be evaluated and the clinician will consider the possibility of a potential return to sport activity the week 8 of follow-up

  22. Return to sport activity at the initial level [ Time Frame: follow visit month 6 ]
    Six months after the intervention, patients will be called to evaluate if they were able to return to a sport activity at the same level they were before the disease. This proportion will be compared in between both groups

  23. alternative options during the study [ Time Frame: follow visit month 6 ]
    Each patient will be ask during the phone interview at 6 months if the consulted another physicians or if they used an alternative to that proposed in our study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Boys and girls
  • From 9 to 15 years old
  • Coming to consult in the Sports' medicine ward
  • Patients diagnosed with Osgood-Schlatter disease defined by a swelling of the anterior tibial tuberosity (ATT) , pain on palpation of the ATT , pain with passive knee flexion , pain thwarted knee extension and soft rays in profile knee radiography according to the classification of Woolfrey and Chandler (types A -C
  • Unilateral or bilateral
  • Previously treated or not
  • Agreed to participate
  • Agreement of the parents to participate
  • Affiliation to national security

Exclusion Criteria:

  • Contraindication to the set-up of vascular access in femoral position (femoral Scarpa wound, aortic dissection)
  • Local infection
  • Hypothermia <32°C
  • Need for implementation of arterial catheter only
  • Need for implementation of venous catheter only

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): NCT02824172


Locations
Layout table for location information
France
Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Jean-Francois LUCCIANI, MD Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02824172    
Other Study ID Numbers: 69HCL16_0404
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2017
Keywords provided by Hospices Civils de Lyon:
Cast immobilization
Complete rest
Osgood Schlatter
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteochondrosis
Bone Diseases
Musculoskeletal Diseases