The Caton-Deschamps Index Reliability in Patellar Stabilization Surgery.

August 30, 2021 updated by: Istituto Ortopedico Galeazzi

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.

Study Overview

Status

Recruiting

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 Type

Observational

Enrollment (Anticipated)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Milan, Italy, 20161
        • Recruiting
        • IRCCS Istituto Ortopedico Galeazzi
        • Contact:
        • Principal Investigator:
          • Elisa G Pandini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caton-Deschamps index reliability
Time Frame: 6 months
To evaluate the reliability of the Caton-Deschamps index in measuring the patellar height for planning the intervention to stabilize the patella
6 months
Pre-operative planning
Time Frame: 6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elisa G Pandini, MD, IRCCS Istituto Ortopedico Galeazzi
  • Study Director: Roberto D'Anchise, MD, IRCCS Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

July 17, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CATON

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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