Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children

Synovitis Clinical Trial

— SVN  

Official title:

Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children in a Retrospective Case Series

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03507933
• Other study ID #: OBS-0033
• Status: Recruiting
• First received: March 7, 2018
• Last updated: April 16, 2018
• Start date: January 30, 2018
• Est. completion date: June 2018

Study information

• Verified date: March 2018
• Source: Lille Catholic University
• Contact: Amélie Lansiaux, MD, PhD
• Phone: + 33 320225269
• Email: lansiaux.amelie[@]ghicl.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Villo-nodular synovitis can affect the joints, bursae or tendon sheaths. This condition is rare, with 1.8 cases per million inhabitants. The hip is affected in 3.6 to 18.1% of cases. The age of predilection is between 30 and 50 years old and this condition is rarely described in children.

Two articles report a case of villous-nodular synovitis of the child's hip. Surgical treatment by resection seems to be consensus but various adjuvant treatments are also proposed. A case of villous-nodular synovitis of the hip in children was treated without surgical intervention. The main objective of this study was to evaluate the efficacy of surgical treatment of villous nodular synovitis of the hip in children.

Description:

French multicentric cases serie

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children with histologically villo-nodular synovitis of the hip

• Surgical procedures performed for the treatment of this synovitis

Exclusion Criteria:

• Degree of bone maturation and Risser test greater than 4 at the time of diagnosis

• Parents opposing the use of their child's data / Patient opposing the use of his/her data

Related Conditions & MeSH terms

• Synovitis
• Synovitis, Pigmented Villonodular

Locations

Country	Name	City	State
France	Lille Catholic University	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the range of motion of the hip in degrees	Evaluation of extension / flexion / abduction / adduction / external rotation / internal rotation of the hip	before surgery and 4 months after surgery
Primary	Incidence of signal changes in the X-Ray		4 months after surgery
Primary	Incidence of signal changes in the MRI		4 months after surgery
Secondary	Change from baseline in the scale measure of patient's pain intensity		before surgery and 4 months after surgery
Secondary	Incidence of complications after surgery		4 month after surgery
Secondary	Number of additional treatments used in addition to surgery	Frequency of adjuvant treatments	4 month after surgery
Secondary	Change from baseline in the physical activity evaluated by a questionnaire	yes /no questionnaire	before surgery and 4 months after surgery