- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02824172
Treatment of the Osgood Schlatter (OSGOOD)
Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69003
- Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cast immobilization
36 patients in the experimental cast immobilization
|
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
|
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Inclusion visit Day 0
|
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
|
follow-up visit week 4
|
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
|
follow-up visit week 8
|
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
|
follow-up visit week 12
|
Pain killer consumption
Time Frame: follow-up visit week 4
|
Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups
|
follow-up visit week 4
|
Pain killer consumption
Time Frame: follow-up visit week 8
|
Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups
|
follow-up visit week 8
|
Quality of life assessment
Time Frame: inclusion visit Day 0
|
Quality of life will be assessed using the SF-12 auto questionnaire
|
inclusion visit Day 0
|
Quality of life assessment
Time Frame: follow-up visit week 12
|
Quality of life will be assessed using the SF-12 auto questionnaire
|
follow-up visit week 12
|
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
|
follow-up visit month 6
|
Activity level assessment
Time Frame: inclusion visit Day 0
|
Activity level will be assessed using the Tegner scale
|
inclusion visit Day 0
|
Activity level assessment
Time Frame: follow-up visit week 12
|
Activity level will be assessed using the Tegner scale
|
follow-up visit week 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
|
follow-up visit month 6
|
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)
|
follow-up visit week 4
|
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.
|
follow-up visit week 12
|
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
|
inclusion visit Day 0
|
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
|
follow-up visit week 4
|
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
|
follow-up visit week 8
|
Patella size
Time Frame: inclusion visit Day 0
|
The patella size will be measure on the lateral radiograph using the Caton and Deschamp index
|
inclusion visit Day 0
|
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
|
follow-up visit week 8
|
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.
|
follow-up visit week 12
|
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
|
follow visit week 8
|
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
|
follow visit month 6
|
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.
|
follow visit month 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Francois LUCCIANI, MD, Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0404
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osgood Schlatter Disease
-
University Hospital, Basel, SwitzerlandCompletedOsgood-Schlatter DiseaseSwitzerland
-
Aalborg UniversityCompletedApophysitis | Osgood-Schlatter DiseaseDenmark
-
Universidad Nacional de RosarioCompleted
-
Hvidovre University HospitalCompleted
-
Aalborg UniversityCompletedOsgood Schlatter DiseaseDenmark
-
Aalborg UniversityRecruitingOsgood-Schlatter DiseaseDenmark
-
Hvidovre University HospitalAalborg University; University College CopenhagenActive, not recruitingApophysitis | Osgood-Schlatter Disease | Osteochondrosis; Tibia | Physeal InjuryDenmark
-
Hvidovre University HospitalCompletedLower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)Denmark
-
Ann & Robert H Lurie Children's Hospital of ChicagoAmerican Medical Society for Sports MedicineUnknownOsgood-Schlatter Syndrome | Sinding-Larsen and Johansson Syndrome | Sever's Disease | ApophysitisUnited States
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
Clinical Trials on cast immobilization group
-
Sundsvall HospitalCompletedDistal Radius Fracture | Radiological OutcomeSweden
-
Ostfold Hospital TrustSykehuset Innlandet HF; Alesund HospitalRecruiting
-
Diakonessenhuis, UtrechtZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruitingUlnar Collateral Ligament Sprain | Skier's ThumbNetherlands
-
Federal University of Rio Grande do SulCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional...CompletedRupture of Achilles Tendon | Rupture, Spontaneous | Immobility Response, TonicBrazil
-
Prisma Health-UpstateCompletedTibial FracturesUnited States
-
University of Sao Paulo General HospitalUnknown
-
Ann & Robert H Lurie Children's Hospital of ChicagoNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingFracture ElbowUnited States
-
Töölö HospitalRecruitingPediatric Overriding Distal Metaphyseal Radius FracturesFinland
-
Queen Savang Vadhana Memorial Hospital, ThailandCompletedClosed Fracture of Lower End of RadiusThailand
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Institute for Clinical Evaluative... and other collaboratorsCompleted