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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • IRCCS Istituto Ortopedico Galeazzi

    Milan, 20161

    Elena Cittera, 00390266214057, elena.cittera@grupposandonato.it

    Elisa G Pandini, MD

    Recruiting

Other trials in Italy

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.

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.

  1. 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)
  1. 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

  2. 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.

  1. First posted31 Aug 2021
  2. Study start12 Jul 2021
  3. Primary completion30 Aug 2021 (estimated)
  4. Study completion1 Oct 2021 (estimated)

Resources

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)
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

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.

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