Patellar InstabilityNCT05029505
The Caton-Deschamps Index Reliability in Patellar Stabilization Surgery.
An observational study of Patellar Instability, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Recurrent patellofemoral instability is a multifactorial pathology based on limb alignment, soft tissue constraints as well as patella and trochlear groove abnormal anatomy. For a correct and effective surgical approach, an accurate radiological evaluation is essential, which consists of the evaluation of three main… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Patellar Instability
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jul 2021to 1 Oct 2021
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from recurrent patellar instability (≥ 2 episodes) with indication of patellar stabilization surgery by reconstruction of the medial patellofemoral ligament and / or transposition of the anterior tibial tuberosity.
Who may be able to join
- Diagnosis of recurrent patellar instability (≥ 2 episodes) at the time of surgery
- Indications for patellar stabilization surgery
- Availability of X-rays in digital format
- Patients who do not meet the inclusion criteria
Who cannot join
- Clinical history of <2 patella dislocations
- Non-availability of X-rays in digital format
- Not indicated for patellar stabilization surgery
- Contraindications to surgery
- Patients with osteoarthritis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Elena Cittera, 00390266214057, elena.cittera@grupposandonato.it
Elisa G Pandini, MD
About this study
Official title: Patellar Stabilization Surgery: Can the Caton-Deschamps Index be Useful in Planning?
Recurrent patellofemoral instability is a multifactorial pathology based on limb alignment, soft tissue constraints as well as patella and trochlear groove abnormal anatomy. For a correct and effective surgical approach, an accurate radiological evaluation is essential, which consists of the evaluation of three main factors of instability: trochlear dysplasia, abnormal height of the patella and pathological distance of the anterior tibial apophysis and trochlear throat (TA-GT). Concerning patellar height, one of the most used methods is the calculation of the Caton-Deschamps radiographic index. However, to date there is no study that certifies its reproducibility and reliability from a pre-operative assessment and planning perspective.
Read the detailed description
The patellofemoral joint (PFJ) consists of two bony components, the patella and the femoral trochlea, sharing the same joint surface (1). It may be prone to instability, that is when the patella dislocates, usually on the lateral side of the knee. The incidence of primary patellar dislocation has been reported to be 5.8 cases per 100,000 in the general population, with the highest incidence occurring in the 2nd decade of life (29 per 100,000) (2). Patellar instability can be classified as traumatic, when the dislocation is caused by an external force, or nontraumatic, when native anatomy of the knee predisposes to instability. Non-operative treatment is usually taken into account for first episode of lateral patellar dislocation, unless the presence of loose bodies is verified, and consists of knee immobilization, physical therapy, non-steroidal anti-inflammatory drugs (NSAIDs) administration (3). Recurrence rate after conservative management can be up to 15-44% and patients with a clinical history of two or more dislocations have a 50% chance of recurrent dislocation episodes (4). Recurrent instability is a multifactorial problem that rely on limb alignment, bone anatomy of the patella and the trochlear groove, soft-tissue constraints, especially the medial patello-femoral ligament (MPFL). The management of recurrent patellar instability is difficult for many reasons, including heterogeneous patient population, skeletal maturity, challenging surgical approach and lack of long-term and robust clinical outcome studies (5,6). Radiologic evaluation should study the three principal factors of instability: trochlear dysplasia, abnormal patellar height, pathological tibial tubercle-trochlear groove (TT-TG) distance (7). Patellar height can be easily assessed, through standard lateral view radiographs. Several indexes for studying and calculating patellar height have been described in the literature (8-10). In patellar instability, the use of Caton-Deschamps index CDI to measure patellar height one of the most employed. Specifically, CDI relies upon the length of the articular surface of the patella and its distance from the tibia. The purpose of our study is to evaluate the reliability and reproducibility of CDI in measuring patellar height for planning patella stabilization surgery. The secondary target is to hypothesize a quantitative method of preoperative planning for anterior tibial apophysis transposition surgery, by calculating CDI.
- Conditions
- Patellar Instability
- Keywords
- Patello-femoral Joint, Caton Deschamps Index, Patellar instability
What is being measured
The primary outcome is the main question the study is designed to answer.
Caton-Deschamps index reproducibility
Evaluation of the Caton-Deschamps index's reproducibility in the measurement of patellar height for planning the intervention to stabilize the patella.
Measured: 6 months
Secondary outcomes (2)
Caton-Deschamps index reliability
To evaluate the reliability of the Caton-Deschamps index in measuring the patellar height for planning the intervention to stabilize the patella
Measured: 6 months
Pre-operative planning
To hypothesize a quantitative method of preoperative planning that allows, using a mathematical calculation, to establish the extent of lowering of the patella in millimeters necessary to obtain a normal value of the Caton-Deschamps index, using radiographs with a reference calibrated at twenty millimeters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start12 Jul 2021
- Primary completion30 Aug 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar InstabilityStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Retrospective
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa G Pandini, MD, Principal investigator, IRCCS Istituto Ortopedico GaleazziRoberto D'Anchise, MD, Study director, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029505
- Sponsor's protocol ID
- CATON
- Status last verified
- Aug 2021
- First submitted
- 17 Jul 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patellar Stabilization Surgery: Can the Caton-Deschamps Index be Useful in Planning?
- ClinicalTrials.gov ID
- NCT05029505
- Acronym / sponsor ID
- CATON
- Conditions
- Patellar Instability
- Keywords
- Patello-femoral Joint, Caton Deschamps Index, Patellar instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 31 Aug 2021 (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.
Recurrent patellofemoral instability is a multifactorial pathology based on limb alignment, soft tissue constraints as well as patella and trochlear groove abnormal anatomy. For a correct and effective surgical approach, an accurate radiological evaluation is essential, which consists of the evaluation of three main factors of instability: trochlear dysplasia, abnormal height of the patella and pathological distance of the anterior tibial apophysis and trochlear throat (TA-GT). Concerning patellar height, one of the most used methods is the calculation of the Caton-Deschamps radiographic index. However, to date there is no study that certifies its reproducibility and reliability from a pre-operative assessment and planning perspective.
Detailed description
The patellofemoral joint (PFJ) consists of two bony components, the patella and the femoral trochlea, sharing the same joint surface (1). It may be prone to instability, that is when the patella dislocates, usually on the lateral side of the knee. The incidence of primary patellar dislocation has been reported to be 5.8 cases per 100,000 in the general population, with the highest incidence occurring in the 2nd decade of life (29 per 100,000) (2). Patellar instability can be classified as traumatic, when the dislocation is caused by an external force, or nontraumatic, when native anatomy of the knee predisposes to instability. Non-operative treatment is usually taken into account for first episode of lateral patellar dislocation, unless the presence of loose bodies is verified, and consists of knee immobilization, physical therapy, non-steroidal anti-inflammatory drugs (NSAIDs) administration (3). Recurrence rate after conservative management can be up to 15-44% and patients with a clinical history of two or more dislocations have a 50% chance of recurrent dislocation episodes (4). Recurrent instability is a multifactorial problem that rely on limb alignment, bone anatomy of the patella and the trochlear groove, soft-tissue constraints, especially the medial patello-femoral ligament (MPFL). The management of recurrent patellar instability is difficult for many reasons, including heterogeneous patient population, skeletal maturity, challenging surgical approach and lack of long-term and robust clinical outcome studies (5,6). Radiologic evaluation should study the three principal factors of instability: trochlear dysplasia, abnormal patellar height, pathological tibial tubercle-trochlear groove (TT-TG) distance (7). Patellar height can be easily assessed, through standard lateral view radiographs. Several indexes for studying and calculating patellar height have been described in the literature (8-10). In patellar instability, the use of Caton-Deschamps index CDI to measure patellar height one of the most employed. Specifically, CDI relies upon the length of the articular surface of the patella and its distance from the tibia. The purpose of our study is to evaluate the reliability and reproducibility of CDI in measuring patellar height for planning patella stabilization surgery. The secondary target is to hypothesize a quantitative method of preoperative planning for anterior tibial apophysis transposition surgery, by calculating CDI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from recurrent patellar instability (≥ 2 episodes) with indication of patellar stabilization surgery by reconstruction of the medial patellofemoral ligament and / or transposition of the anterior tibial tuberosity.
Key inclusion criteria (4 listed)
- Diagnosis of recurrent patellar instability (≥ 2 episodes) at the time of surgery
- Indications for patellar stabilization surgery
- Availability of X-rays in digital format
- Patients who do not meet the inclusion criteria
Key exclusion criteria (5 listed)
- Clinical history of <2 patella dislocations
- Non-availability of X-rays in digital format
- Not indicated for patellar stabilization surgery
- Contraindications to surgery
- Patients with osteoarthritis
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
Caton-Deschamps index reproducibility
Time frame: 6 months
Evaluation of the Caton-Deschamps index's reproducibility in the measurement of patellar height for planning the intervention to stabilize the patella.
2 secondary outcomes
Caton-Deschamps index reliability
Time frame: 6 months
Pre-operative planning
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
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JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
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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.
Elisa G Pandini, MD principal investigator
IRCCS Istituto Ortopedico Galeazzi
Roberto D'Anchise, MD study director
IRCCS Istituto Ortopedico Galeazzi
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, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 4 inclusion and 5 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 31 Aug 2021. 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 Italy. 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 Elena Cittera (00390266214057, elena.cittera@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caton-Deschamps index reproducibility (time frame: 6 months). 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 31 Aug 2021.