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

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ClinicalTrials.gov Identifier: NCT03507933
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Synovitis

Detailed Description:
French multicentric cases serie

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Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children in a Retrospective Case Series
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. Incidence of signal changes in the X-Ray [ Time Frame: 4 months after surgery ]
  3. Incidence of signal changes in the MRI [ Time Frame: 4 months after surgery ]

Secondary Outcome Measures :
  1. Change from baseline in the scale measure of patient's pain intensity [ Time Frame: before surgery and 4 months after surgery ]
  2. Incidence of complications after surgery [ Time Frame: 4 month after surgery ]
  3. Number of additional treatments used in addition to surgery [ Time Frame: 4 month after surgery ]
    Frequency of adjuvant treatments

  4. Change from baseline in the physical activity evaluated by a questionnaire [ Time Frame: before surgery and 4 months after surgery ]
    yes /no questionnaire



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Children operated for villo-nodular synovitis of the hip
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507933


Contacts
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Contact: Amélie Lansiaux, MD, PhD + 33 320225269 lansiaux.amelie@ghicl.net
Contact: Justine Monvoisin +33 320223884 monvoisin.justine@ghicl.net

Locations
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France
Lille Catholic University Recruiting
Lille, France, 59000
Sponsors and Collaborators
Lille Catholic University
Investigators
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Principal Investigator: Raphael Coursier, MD Lille Catholic University

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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03507933     History of Changes
Other Study ID Numbers: OBS-0033
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
villo-nodular synovitis
Hip
Surgery
Additional relevant MeSH terms:
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Synovitis, Pigmented Villonodular
Synovitis
Joint Diseases
Musculoskeletal Diseases
Giant Cell Tumor of Tendon Sheath
Giant Cell Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Tendinopathy
Muscular Diseases