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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05029505
Other study ID # CATON
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 12, 2021
Est. completion date October 1, 2021

Study information

Verified date August 2021
Source Istituto Ortopedico Galeazzi
Contact Elena Cittera
Phone 00390266214057
Email elena.cittera@grupposandonato.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 29
Est. completion date October 1, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary 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 6 months
Secondary 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 6 months
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Terminated NCT00816647 - A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction N/A
Completed NCT04438109 - Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL)
Completed NCT04378491 - Clinical and Functional Outcome After Lateral Trochlear Lengthening Osteotomy Lateral Trochlear Lengthening Osteotomy
Completed NCT03304119 - Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?