Treatment of the Osgood Schlatter

Osgood Schlatter Disease Clinical Trial

— OSGOOD  

Official title:

Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824172
• Other study ID #: 69HCL16_0404
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Osgood Schlatter Disease

Intervention

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.
• 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 .

Locations

Country	Name	City	State
France	Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restarting a sporting activity	Comparison between the 2 groups of the proportion of patient returning to sports activity 12 weeks after treatment.	12 weeks after intervention
Secondary	Anterior tibial tuberosity pain	Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation	Inclusion visit Day 0
Secondary	Anterior tibial tuberosity pain	Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation	follow-up visit week 4
Secondary	Anterior tibial tuberosity pain	Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation	follow-up visit week 8
Secondary	Anterior tibial tuberosity pain	Mean pain evaluation using Visual analogic scale between the 2 groups, at Anterior tibial tuberosity palpation	follow-up visit week 12
Secondary	Pain killer consumption	Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups	follow-up visit week 4
Secondary	Pain killer consumption	Evaluation of pain killer consumption (type, dose ,frequency) between the 2 groups	follow-up visit week 8
Secondary	Quality of life assessment	Quality of life will be assessed using the SF-12 auto questionnaire	inclusion visit Day 0
Secondary	Quality of life assessment	Quality of life will be assessed using the SF-12 auto questionnaire	follow-up visit week 12
Secondary	Quality of life assessment	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
Secondary	Activity level assessment	Activity level will be assessed using the Tegner scale	inclusion visit Day 0
Secondary	Activity level assessment	Activity level will be assessed using the Tegner scale	follow-up visit week 12
Secondary	Activity level assessment	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
Secondary	complete sport rest compliance assessment	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
Secondary	painfulness due to immobilization cast	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
Secondary	Quadricipital shortness	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
Secondary	Quadricipital shortness	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
Secondary	Quadricipital shortness	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
Secondary	Patella size	The patella size will be measure on the lateral radiograph using the Caton and Deschamp index	inclusion visit Day 0
Secondary	Patella size	The patella size will be measure on the lateral radiograph using the Caton and Deschamp index	follow-up visit week 8
Secondary	Radiographic evolution of Osgood Schlatter disease	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
Secondary	Potential return to sport activity	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
Secondary	Return to sport activity at the initial level	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
Secondary	alternative options during the study	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