Skip to main content
Clinical Trials/NCT03441659
NCT03441659
Recruiting
Not Applicable

Anterior Cruciate Ligament Reconstruction: Clinical Outcome at Middle and Long Term Follow-Up

Stefano Zaffagnini1 site in 1 country1,000 target enrollmentDecember 17, 2020
ConditionsACL Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ACL Injury
Sponsor
Stefano Zaffagnini
Enrollment
1000
Locations
1
Primary Endpoint
Knee Laxity Assessment
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1, 2 and 5 years after the intervention through a clinical visit or telephone interview. Such assessments will include the administration of questionnaires to determine the patient's functional symptoms and the objective examination of the knee during a medical examination to quantify its stability.

Detailed Description

The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the clinical outcomes remains largely debated. The study aims to offer new elements to analyze this treatment and potentially identify the factors responsible for the outcomes and the factors useful to optimize the clinical outcome in the future. In fact, in addition to collect patient data in terms of features and clinical-functional status, objective data will be documented and correlated. In particular the quantification of knee laxity will be performed using an innovative device based on the use of inertial sensors (a methodology recently developed and already validated at the Istituto Ortopedico Rizzoli). The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1, 2 and 5 years after surgery during a clinical visit or a telephone interview. Such evaluations will include the submission of questionnaires to determine the patient's functional symptoms and also knee joint assessment during a medical examination to quantify the knee joint stability. Moreover, the following clinical scores will be adopted: IKDC-subjective, IKDC-objective, SF12, Marxs, Koos, Tegner, VAS for pain assessment, EQ-VAS for overall health status assessment. Also it will be recorded the lapse of time for returning to work and sports, the degree of patient satisfaction,the adverse events, the failures and any new treatments on the same site.

Registry
clinicaltrials.gov
Start Date
December 17, 2020
End Date
December 1, 2030
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Stefano Zaffagnini

Prof

Istituto Ortopedico Rizzoli

Eligibility Criteria

Inclusion Criteria

  • Patients who have provided informed written written consent;
  • Patients aged between 18 and 60;
  • Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)

Exclusion Criteria

  • Patients unable to understand and to want;
  • Patients who have not signed informed consent;

Outcomes

Primary Outcomes

Knee Laxity Assessment

Time Frame: 5 years

Laxity Evaluation with KiRA device

Secondary Outcomes

  • VAS Score(5 years)
  • SF12 Score(5 years)
  • Marx Activity Rating Score(5 years)
  • IKDC Score(5 years)
  • KOOS Score(5 years)

Study Sites (1)

Loading locations...

Similar Trials