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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has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.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

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Keywords

  • villo-nodular synovitis
  • Hip
  • Surgery
03

In context

Synovitis

53 studies on the registry are indexed under Synovitis; 12 are open to participants now.

This study's planned enrollment of 6 is below the median of 100 across 22 observational studies indexed under Synovitis.

Browse Synovitis studies →

Lead sponsor

Lille Catholic University is the lead sponsor of 112 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
6 participants (estimated)
Patient registry
No
06

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

07

Study locations

1 of 1 sites recruiting
  • Lille Catholic University
    Lille, 59000, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Jun 2018, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2018
First posted
Apr 25, 2018
StartActual
Jan 30, 2018
Primary completionEst.
Jun 2018
CompletionEst.
Jun 2018
Last update
Apr 25, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03507933
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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