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

• Conditions: Synovitis

• Registration Number: NCT03507933
• Lead Sponsor: Lille Catholic University

Brief 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.

Detailed Description

French multicentric cases serie

Study Timeline

• Study Start: 2018-01-30
• Status Verified: 2018-03
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-04-16
• Last Update Submitted: 2018-04-16
• Study First Posted: 2018-04-25
• Last Update Posted: 2018-04-25
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in the range of motion of the hip in degrees	before surgery and 4 months after surgery	Evaluation of extension / flexion / abduction / adduction / external rotation / internal rotation of the hip
Incidence of signal changes in the MRI	4 months after surgery
Incidence of signal changes in the X-Ray	4 months after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of complications after surgery	4 month after surgery
Number of additional treatments used in addition to surgery	4 month after surgery	Frequency of adjuvant treatments
Change from baseline in the physical activity evaluated by a questionnaire	before surgery and 4 months after surgery	yes /no questionnaire
Change from baseline in the scale measure of patient's pain intensity	before surgery and 4 months after surgery

Trial Locations

Locations (1)

Lille Catholic University; 🇫🇷 Lille, France