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.
