NCT05029505

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

July 17, 2021

Last Update Submit

August 30, 2021

Conditions

Keywords

Patello-femoral JointCaton Deschamps IndexPatellar instability

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (2)

  • Caton-Deschamps index reliability

    6 months

  • Pre-operative planning

    6 months

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosis of recurrent patellar instability (≥ 2 episodes) at the time of surgery
  • Indications for patellar stabilization surgery
  • Availability of X-rays in digital format

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

Study Officials

  • Elisa G Pandini, MD

    IRCCS Istituto Ortopedico Galeazzi

    PRINCIPAL INVESTIGATOR
  • Roberto D'Anchise, MD

    IRCCS Istituto Ortopedico Galeazzi

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2021

First Posted

August 31, 2021

Study Start

July 12, 2021

Primary Completion

August 30, 2021

Study Completion

October 1, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations