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

April 16, 2018 updated by: Lille Catholic University

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

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

French multicentric cases serie

Study Type

Observational

Enrollment (Anticipated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Recruiting
        • Lille Catholic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children operated for villo-nodular synovitis of the hip

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the range of motion of the hip in degrees
Time Frame: before surgery and 4 months after surgery
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
Time Frame: 4 months after surgery
4 months after surgery
Incidence of signal changes in the MRI
Time Frame: 4 months after surgery
4 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Raphael Coursier, MD, Lille Catholic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2018

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (ACTUAL)

April 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBS-0033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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