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Effect of Biophysical Stimulation on Intraspongious Bone Edema in Anterior Cruciate Ligament Reconstruction

NCT04255407 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-05-31

No results posted yet for this study

Summary

The following study has as main objective to evaluate whether the use of I-ONE® therapy can reduce post-operative pain thanks to the modulation of inflammation in patients with bone bruise on the knee after anterior cruciate ligament (ACL) injury if applied 15 days before and 60 days after ACL reconstruction surgery for 4 hours a day compared to a control group (no-treatment). Both groups will be able to take anti-inflammatory drugs for pain control as per normal clinical practice.

The secondary objective of the study are: quantify the reduction in the size of the bone bruise area, improving the level of knee function and the amount of anti-inflammatory drugs used in the aforementioned patients in the postoperative period compared to a control group.

Conditions

  • ACL Injury
  • Pain
  • Magnetic Field Exposure

Interventions

DEVICE

I-ONE® therapy

I-ONE® therapy will be used in patients with bone bruise on the knee after anterior cruciate ligament (ACL) injury 15 days before and 60 days after ACL reconstruction surgery for 4 hours a day compared to a control group (no-treatment).

DRUG

Anti-inflammatory drug

Pain before and after ACL reconstruction will be managed with common anti-inflammatory drugs (Paracetamol)

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Stefano Zaffagnini, MD, PhD · IRCCS Istituto Ortopedico Rizzoli

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2023-05-26
Completion
2023-05-26

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255407 on ClinicalTrials.gov