Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children
SVN
1 other identifier
observational
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2018
CompletedFirst Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
April 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedApril 25, 2018
March 1, 2018
4 months
March 7, 2018
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Incidence of signal changes in the X-Ray
4 months after surgery
Incidence of signal changes in the MRI
4 months after surgery
Secondary Outcomes (4)
Change from baseline in the scale measure of patient's pain intensity
before surgery and 4 months after surgery
Incidence of complications after surgery
4 month after surgery
Number of additional treatments used in addition to surgery
4 month after surgery
Change from baseline in the physical activity evaluated by a questionnaire
before surgery and 4 months after surgery
Eligibility Criteria
Children operated for villo-nodular synovitis of the hip
You may qualify if:
- Children with histologically villo-nodular synovitis of the hip
- Surgical procedures performed for the treatment of this synovitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lille Catholic University
Lille, 59000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raphael Coursier, MD
Lille Catholic University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
April 25, 2018
Study Start
January 30, 2018
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
April 25, 2018
Record last verified: 2018-03