NCT03507933

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 25, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

March 7, 2018

Last Update Submit

April 16, 2018

Conditions

Keywords

villo-nodular synovitisHipSurgery

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

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Synovitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Raphael Coursier, MD

    Lille Catholic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Lansiaux, MD, PhD

CONTACT

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

Locations