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Status unknownNCT03507933SVNUpdated Apr 25, 2018

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

An observational study in Synovitis, sponsored by Lille Catholic University. Status unknown at 1 site in France. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-04-25.

Sponsored by Lille Catholic University · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
6
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

Read the detailed description

French multicentric cases serie

02

Conditions studied

  • Synovitis

Browse trials for

Keywords

  • villo-nodular synovitis
  • Hip
  • Surgery
03

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children operated for villo-nodular synovitis of the hip

Inclusion criteria

  • Children with histologically villo-nodular synovitis of the hip
  • Surgical procedures performed for the treatment of this synovitis

Exclusion criteria

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
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
6 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: before surgery and 4 months after surgery

  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 outcomes

  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

    Frequency of adjuvant treatments

    Time frame: 4 month after surgery

  4. Change from baseline in the physical activity evaluated by a questionnaire

    yes /no questionnaire

    Time frame: before surgery and 4 months after surgery

06

Study locations

1 of 1 sites recruiting
  • Lille Catholic University
    Lille, 59000, France
    Recruiting
07

Registry details

Key details

Study ID
NCT03507933
Lead sponsor
Lille Catholic University
Responsible party
Sponsor
First posted
Apr 25, 2018
Start date
Jan 30, 2018
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Apr 25, 2018

Study contacts

Amélie Lansiaux, MD, PhD
Contact
lansiaux.amelie@ghicl.net
+ 33 320225269
Justine Monvoisin
Contact
monvoisin.justine@ghicl.net
+33 320223884
Raphael Coursier, MD
principal investigator · Lille Catholic University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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