Patellar InstabilityNCT03304119
Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?
An observational study of Patellar Instability and Patellar Dislocation, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often seen in young subjects, especially among adolescents. It is commonly accompanied by anatomical factors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patellar Instability, Patellar Dislocation
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2016to 30 Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: group of patients with patellar instability stemming from a recurrent patellar dislocationand a control group that has not been checked for patellar instability.
Who may be able to join
- Men or women
- Subjects who have not expressed opposition to the use of the data for research purposes
- Clinical criteria:
- Unstable group:
- Medical history with 2 patellar dislocations or more,
- with or without requiring surgical treatment after an MRI Control group: Men or women over 18 years old
Show all 9Show fewer
- Subjects who have not expressed opposition to the use of the data for research purposes
- Control group:
- Patients showing meniscal injury on MRI who may or may not have been treated (meniscectomy or stitches)
Who cannot join
- Unstable group:
- MRI performed on one knee operated for patellar instability
- Associated tearing of the ligament (ACL, PCL)
- Control group:
- Patients with a medical history of patellar pathology
- Patients with associated ligament injury (ACL, PCL)
Trial locations and contacts
1 site in 1 country.
About this study
Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often seen in young subjects, especially among adolescents. It is commonly accompanied by anatomical factors. A new factor not described in bibliographic sources and characterized by an external torsion of the tibial tuberosity is frequently found in patients with patellar instability thanks to MRIs. This does not seem to be the case when there is no patellar pathology. A statistical study is needed to assess this rotary anomaly. Validate the predictive benefits when measuring the torsion of tibial tuberosity in cases with recurrent patellar dislocation.
Read the detailed description
Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often seen in young subjects, especially among adolescents. It is commonly accompanied by anatomical factors known to be driving: Dysplasia of the trochlea, patella alta, lateralisation of the tibial tuberosity, patellar torsion and misalignment, tearing of the Medial Patello Femoral Ligament... The assessment of these factors is essential to evaluate the instability and guide the procedures of the surgical treatment. MRIs have become an important test for the analysis and measurement of these factors. A new factor not described in bibliographic sources and characterized by an external torsion of the tibial tuberosity is frequently found in patients with patellar instability thanks to MRIs. This does not seem to be the case when there is no patellar pathology. A statistical study is needed to assess this rotary anomaly. It will be necessary to take it into account in the future regarding indications and techniques for tibial tuberosity osteotomies, often used to correct patellar instability.
- Conditions
- Patellar Instability, Patellar Dislocation
- Keywords
- Torsion of tibial tuberosity, Recurrent patellar dislocation, MRI Measurements, Patellar instability, Patellar dislocation, Tibial tubercle position, Tibial tubercle torsion
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patellar instability group | Group of patients with patellar instability stemming from a recurrent patellar dislocation | |
| Control group control | Group that has not been checked for patellar instability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Existence of Tibial Tuberosity Torsion.
This criteria will be considered relevant if it is associated with patellar dislocation. Existence Yes or No and measure of the torsion in degre on the IRM
Measured: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
Secondary outcomes (2)
Measure of Patellar Tilt
Patellar Tilt (yes or no), based on a patient IRM. Unit in degre.
Measured: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable. Unit in degre
Distance TT-TG Tibial Tuberosity and Trochlear Groove
distance between Tibial Tuberosity and Trochlear Groove
Measured: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Apr 2016
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Patellar InstabilityStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Vincent Chassaing, European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304119
- Sponsor's protocol ID
- RGDS TTA study
- Status last verified
- Feb 2018
- First submitted
- 26 Sep 2017
- Last updated
- 20 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skelley N, Friedman M, McGinnis M, Smith C, Hillen T, Matava M. Inter- and intraobserver reliability in the MRI measurement of the tibial tubercle-trochlear groove distance and trochlea dysplasia. Am J Sports Med. 2015 Apr;43(4):873-8. doi: 10.1177/0363546514565768. Epub 2015 Jan 28.
PubMed 25632054The Patellofemoral Joint - State of the Art in Evaluation and Management. ISAKOS 2014. Alberto Gobbi, Joao Espregueira-Mendes, Norima Nakamura Editors
Diederichs G, Issever AS, Scheffler S. MR imaging of patellar instability: injury patterns and assessment of risk factors. Radiographics. 2010 Jul-Aug;30(4):961-81. doi: 10.1148/rg.304095755.
PubMed 20631363Biedert RM. [Osteotomies]. Orthopade. 2008 Sep;37(9):872, 874-6, 878-80 passim. doi: 10.1007/s00132-008-1294-5. German.
PubMed 18682913Pache T, Meystre JL, Delgado-Martins H, Schnyder P. [Transplantation of the anterior tibial tubercle by the Elmslie-Trillat technic. Indications as a function of morphotype]. Rev Chir Orthop Reparatrice Appar Mot. 1985;71(6):359-64. French.
PubMed 4081137Rhee SJ, Pavlou G, Oakley J, Barlow D, Haddad F. Modern management of patellar instability. Int Orthop. 2012 Dec;36(12):2447-56. doi: 10.1007/s00264-012-1669-4. Epub 2012 Oct 7.
PubMed 23052278Guilbert S, Chassaing V, Radier C, Hulet C, Remy F, Chouteau J, Chotel F, Boisrenoult P, Sebilo A, Ferrua P, Ehkirch FP, Bertin D, Dejour D; French Arthroscopy Society (SFA). Axial MRI index of patellar engagement: a new method to assess patellar instability. Orthop Traumatol Surg Res. 2013 Dec;99(8 Suppl):S399-405. doi: 10.1016/j.otsr.2013.10.006. Epub 2013 Nov 20.
PubMed 24268843
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?
- ClinicalTrials.gov ID
- NCT03304119
- Acronym / sponsor ID
- RGDS TTA study
- Conditions
- Patellar Instability, Patellar Dislocation
- Keywords
- Torsion of tibial tuberosity, Recurrent patellar dislocation, MRI Measurements, Patellar instability, Patellar dislocation, Tibial tubercle position, Tibial tubercle torsion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Dr Vincent Chassaing, European Clinical Trial Experts Network
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Posted 11 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often seen in young subjects, especially among adolescents. It is commonly accompanied by anatomical factors. A new factor not described in bibliographic sources and characterized by an external torsion of the tibial tuberosity is frequently found in patients with patellar instability thanks to MRIs. This does not seem to be the case when there is no patellar pathology. A statistical study is needed to assess this rotary anomaly. Validate the predictive benefits when measuring the torsion of tibial tuberosity in cases with recurrent patellar dislocation.
Detailed description
Patellar instability (recurrent patellar dislocation) can occur at any age. It is most often seen in young subjects, especially among adolescents. It is commonly accompanied by anatomical factors known to be driving: Dysplasia of the trochlea, patella alta, lateralisation of the tibial tuberosity, patellar torsion and misalignment, tearing of the Medial Patello Femoral Ligament... The assessment of these factors is essential to evaluate the instability and guide the procedures of the surgical treatment. MRIs have become an important test for the analysis and measurement of these factors. A new factor not described in bibliographic sources and characterized by an external torsion of the tibial tuberosity is frequently found in patients with patellar instability thanks to MRIs. This does not seem to be the case when there is no patellar pathology. A statistical study is needed to assess this rotary anomaly. It will be necessary to take it into account in the future regarding indications and techniques for tibial tuberosity osteotomies, often used to correct patellar instability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patellar instability group | – | –Group of patients with patellar instability stemming from a recurrent patellar dislocation |
| Control group control | – | –Group that has not been checked for patellar instability. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- group of patients with patellar instability stemming from a recurrent patellar dislocationand a control group that has not been checked for patellar instability.
Key inclusion criteria (9 listed)
- Men or women
- Subjects who have not expressed opposition to the use of the data for research purposes
- Unstable group:
- Control group:
Key exclusion criteria (6 listed)
- Unstable group:
- Control group:
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
Existence of Tibial Tuberosity Torsion.
Time frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
This criteria will be considered relevant if it is associated with patellar dislocation. Existence Yes or No and measure of the torsion in degre on the IRM
2 secondary outcomes
Measure of Patellar Tilt
Time frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable. Unit in degre
Distance TT-TG Tibial Tuberosity and Trochlear Groove
Time frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25632054Skelley N, Friedman M, McGinnis M, Smith C, Hillen T, Matava M. Inter- and intraobserver reliability in the MRI measurement of the tibial tubercle-trochlear groove distance and trochlea dysplasia. Am J Sports Med. 2015 Apr;43(4):873-8. doi: 10.1177/0363546514565768. Epub 2015 Jan 28.
- BackgroundThe Patellofemoral Joint - State of the Art in Evaluation and Management. ISAKOS 2014. Alberto Gobbi, Joao Espregueira-Mendes, Norima Nakamura Editors
- Background: PubMed 20631363Diederichs G, Issever AS, Scheffler S. MR imaging of patellar instability: injury patterns and assessment of risk factors. Radiographics. 2010 Jul-Aug;30(4):961-81. doi: 10.1148/rg.304095755.
- Background: PubMed 18682913Biedert RM. [Osteotomies]. Orthopade. 2008 Sep;37(9):872, 874-6, 878-80 passim. doi: 10.1007/s00132-008-1294-5. German.
- Background: PubMed 4081137Pache T, Meystre JL, Delgado-Martins H, Schnyder P. [Transplantation of the anterior tibial tubercle by the Elmslie-Trillat technic. Indications as a function of morphotype]. Rev Chir Orthop Reparatrice Appar Mot. 1985;71(6):359-64. French.
- Background: PubMed 23052278Rhee SJ, Pavlou G, Oakley J, Barlow D, Haddad F. Modern management of patellar instability. Int Orthop. 2012 Dec;36(12):2447-56. doi: 10.1007/s00264-012-1669-4. Epub 2012 Oct 7.
- Background: PubMed 24268843Guilbert S, Chassaing V, Radier C, Hulet C, Remy F, Chouteau J, Chotel F, Boisrenoult P, Sebilo A, Ferrua P, Ehkirch FP, Bertin D, Dejour D; French Arthroscopy Society (SFA). Axial MRI index of patellar engagement: a new method to assess patellar instability. Orthop Traumatol Surg Res. 2013 Dec;99(8 Suppl):S399-405. doi: 10.1016/j.otsr.2013.10.006. Epub 2013 Nov 20.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patellar Instability and Patellar Dislocation, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 20 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Existence of Tibial Tuberosity Torsion. (time frame: 4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03304119, which also lists 7 linked publications.
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 20 Mar 2019.