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The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

Primary Purpose

Cruciate Ligament Rupture, Cartilage Injury

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Nanofractures
no treatment cartilaginous lesions
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cruciate Ligament Rupture

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients, 18 < age < 55;
  2. Patients with complete ACL injury candidates for surgical reconstruction of the same;
  3. Cartilaginous lesion of the femur-tibial compartment of grade III-IV ICRS ≤3 cm2 confirmed intra-operatively;
  4. Patients without evidence of osteoarthritis
  5. Patients' ability and consent to participate in clinical and radiological follow-up;
  6. Signature of informed consent.

Exclusion Criteria:

  1. Patients incapable of understanding and of wanting;
  2. State of immunodepression;
  3. Patients with malignant neoplasms;
  4. Patients suffering from rheumatic diseases;
  5. Patients suffering from non-compensated diabetes;
  6. Patients suffering from uncompensated thyroid metabolic disorders;
  7. Patients abusing alcoholic beverages, drugs or drugs;
  8. Patients with axial deviations> 5 °;
  9. Body Mass Index> 35;
  10. Patients treated with surgery at the same knee in the previous 12 months.
  11. Cartilaginous lesions grade I-II according to the ICRS score.
  12. Cartilage lesions with a diameter greater than 3 cm².
  13. Non-suturable meniscal lesions requiring meniscectomy> 50% and patients with previous meniscectomies> 50% in the same compartment.
  14. Need for further associated surgical procedures in addition to the reconstruction of ACL and possibly the nanofractures.

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nanofractures treatment of the cartilaginous lesions

no treatment of the cartilaginous lesions

Arm Description

Patients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique.

Patients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated

Outcomes

Primary Outcome Measures

IKDC-subjective score (International Knee Documentation Committee)
It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function.
WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Magnetic resonance imaging will be evaluated through WORMS. The score evaluated five aspects of the three knee compartments (cartilage, bone marrow abnormalities, bone cysts, bone attrition and osteophytes) as well as the soft tissue (menisci, ligaments and synovium)

Secondary Outcome Measures

IKDC-subjective score (International Knee Documentation Committee)
It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function.
Tegner Activity Level Scale
Survey useful for assessing sport activity of the patient.
KOOS (Knee injury and Osteoarthritis Outcome Score )
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale
EQ-5D (EuroQoL) Current Health Assessment
It is a reliable tools for assessing quality of life of the patient

Full Information

First Posted
November 28, 2019
Last Updated
May 10, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT04184687
Brief Title
The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
Official Title
Randomized Study on the Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
July 25, 2027 (Anticipated)
Study Completion Date
July 25, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study is the evaluation of both clinical and radiological results in patients undergone to cruciate ligament reconstruction with concomitant cartilaginous lesion treated with or without nanofractures.
Detailed Description
The anterior cruciate ligament lesion is one of the most common disease conditions in the orthopedic clinical practice. The mechanism of injury is due to a direct or indirect knee trauma causing both ligamentous breaking and surface articular stress, with cartilaginous lesion often associated to the lesion of the anterior cruciate ligament. The treatment of these lesions in combination with the treatment of the anterior cruciate ligament is controversial, more controversial is to understand the indication to treatment for these lesions. In order to clarify this aspect and provide a more reliable therapeutic indication for the treatment of the cartilaginous lesion with concomitant anterior cruciate ligament lesion we want to compare the clinical outcomes of the non-treated cartilaginous lesions against the treated cartilaginous lesions wiht nonofractures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cruciate Ligament Rupture, Cartilage Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nanofractures treatment of the cartilaginous lesions
Arm Type
Experimental
Arm Description
Patients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique.
Arm Title
no treatment of the cartilaginous lesions
Arm Type
Active Comparator
Arm Description
Patients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated
Intervention Type
Procedure
Intervention Name(s)
Nanofractures
Intervention Description
anterior cruciate ligament reconstruction will be performed in combination with the nanofractures for the treatment of cartilaginous lesions
Intervention Type
Procedure
Intervention Name(s)
no treatment cartilaginous lesions
Intervention Description
patient undergoing to the anterior cruciate ligament reconstruction without treatment of the cartilaginous lesions
Primary Outcome Measure Information:
Title
IKDC-subjective score (International Knee Documentation Committee)
Description
It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function.
Time Frame
24 month
Title
WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Description
Magnetic resonance imaging will be evaluated through WORMS. The score evaluated five aspects of the three knee compartments (cartilage, bone marrow abnormalities, bone cysts, bone attrition and osteophytes) as well as the soft tissue (menisci, ligaments and synovium)
Time Frame
24 month
Secondary Outcome Measure Information:
Title
IKDC-subjective score (International Knee Documentation Committee)
Description
It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function.
Time Frame
6, 12, 36 and 60 months
Title
Tegner Activity Level Scale
Description
Survey useful for assessing sport activity of the patient.
Time Frame
6, 12, 24, 36 and 60 months
Title
KOOS (Knee injury and Osteoarthritis Outcome Score )
Description
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale
Time Frame
6, 12, 24, 36 and 60 months
Title
EQ-5D (EuroQoL) Current Health Assessment
Description
It is a reliable tools for assessing quality of life of the patient
Time Frame
6, 12, 24, 36 and 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients, 18 < age < 55; Patients with complete ACL injury candidates for surgical reconstruction of the same; Cartilaginous lesion of the femur-tibial compartment of grade III-IV ICRS ≤3 cm2 confirmed intra-operatively; Patients without evidence of osteoarthritis Patients' ability and consent to participate in clinical and radiological follow-up; Signature of informed consent. Exclusion Criteria: Patients incapable of understanding and of wanting; State of immunodepression; Patients with malignant neoplasms; Patients suffering from rheumatic diseases; Patients suffering from non-compensated diabetes; Patients suffering from uncompensated thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs or drugs; Patients with axial deviations> 5 °; Body Mass Index> 35; Patients treated with surgery at the same knee in the previous 12 months. Cartilaginous lesions grade I-II according to the ICRS score. Cartilage lesions with a diameter greater than 3 cm². Non-suturable meniscal lesions requiring meniscectomy> 50% and patients with previous meniscectomies> 50% in the same compartment. Need for further associated surgical procedures in addition to the reconstruction of ACL and possibly the nanofractures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Di Martino
Phone
0516366567
Email
alessandro.dimartino@ior.it
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro DI Martino
Phone
0516366567
Email
alessandro.dimartino@ior.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
27043346
Citation
Filardo G, de Caro F, Andriolo L, Kon E, Zaffagnini S, Marcacci M. Do cartilage lesions affect the clinical outcome of anterior cruciate ligament reconstruction? A systematic review. Knee Surg Sports Traumatol Arthrosc. 2017 Oct;25(10):3061-3075. doi: 10.1007/s00167-016-4097-y. Epub 2016 Apr 4.
Results Reference
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PubMed Identifier
20117635
Citation
Brophy RH, Zeltser D, Wright RW, Flanigan D. Anterior cruciate ligament reconstruction and concomitant articular cartilage injury: incidence and treatment. Arthroscopy. 2010 Jan;26(1):112-20. doi: 10.1016/j.arthro.2009.09.002.
Results Reference
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The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

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