SynovitisSVNNCT03507933
Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children
An observational study of Synovitis, run by Lille Catholic University at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Synovitis
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2018to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Child, Adult
Study population: Children operated for villo-nodular synovitis of the hip
Who may be able to join
- Children with histologically villo-nodular synovitis of the hip
- Surgical procedures performed for the treatment of this synovitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
French multicentric cases serie
- Conditions
- Synovitis
- Keywords
- villo-nodular synovitis, Hip, Surgery
- Medical subject headings
- Synovitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before surgery and 4 months after surgery
Incidence of signal changes in the X-Ray
Measured: 4 months after surgery
Incidence of signal changes in the MRI
Measured: 4 months after surgery
Secondary outcomes (4)
Change from baseline in the scale measure of patient's pain intensity
Measured: before surgery and 4 months after surgery
Incidence of complications after surgery
Measured: 4 month after surgery
Number of additional treatments used in addition to surgery
Frequency of adjuvant treatments
Measured: 4 month after surgery
Change from baseline in the physical activity evaluated by a questionnaire
yes /no questionnaire
Measured: before surgery and 4 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start30 Jan 2018
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SynovitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael Coursier, MD, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507933
- Sponsor's protocol ID
- OBS-0033
- Acronym
- SVN
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Surgical Treatment of Villo-nodular Synovitis of the Hip in Children in a Retrospective Case Series
- ClinicalTrials.gov ID
- NCT03507933
- Acronym / sponsor ID
- SVN / OBS-0033
- Conditions
- Synovitis
- Keywords
- villo-nodular synovitis, Hip, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
French multicentric cases serie
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children operated for villo-nodular synovitis of the hip
Key inclusion criteria (2 listed)
- Children with histologically villo-nodular synovitis of the hip
- Surgical procedures performed for the treatment of this synovitis
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Incidence of signal changes in the X-Ray
Time frame: 4 months after surgery
Incidence of signal changes in the MRI
Time frame: 4 months after surgery
4 secondary outcomes
Change from baseline in the scale measure of patient's pain intensity
Time frame: before surgery and 4 months after surgery
Incidence of complications after surgery
Time frame: 4 month after surgery
Number of additional treatments used in addition to surgery
Time frame: 4 month after surgery
Change from baseline in the physical activity evaluated by a questionnaire
Time frame: before surgery and 4 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Coursier, MD principal investigator
Lille Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Synovitis, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie Lansiaux, MD, PhD (+ 33 320225269, lansiaux.amelie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the range of motion of the hip in degrees (time frame: before surgery and 4 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.