Treatment of Bone Marrow Edema Lesions of the Knee With Percutaneous Grafting

Summary

Objective

1. To evaluate the technique of percutaneous grafting with bone substitute in the knee as to its applicability and technical feasibility.
2. Evaluate the results regarding functional improvement and prevention of the evolution of joint cartilage degeneration.

Material and methods Twenty patients from the Knee Group clinic who meet the criteria will be selected.

Magnetic resonance imaging will be analyzed on the PACS server. Through the resonance will be performed evaluation of the size of the bone edema in volume and its proportion in relation to the size of the affected condyle or tibial plateau and the cartilage of the femoro-tibial joint. The lesions will then be mapped in the coronal and sagittal plane.

Radiographs will be taken in antero-posterior, profile, Rosenberg knee and lower limb views.

Evaluation of the patients will be performed by the visual analog pain scale and by the KOOS, IKDC and SF-36v1 indices.

Description of Surgical Technique After the mapping the patient will be submitted to the procedure. The procedure consists in the application of a bone substitute based on injectable calcium phosphate in the area of bone edema previously mapped with the aid of radioscopy to guide. After confirming the proper positioning of the guidewire, a trephine is introduced through which the product will be injected. GRAFTYS HBS® (Graftys, Aix en Provence, France) will be used.

The procedures will be performed in a surgical center, with conventional antisepsis and asepsis techniques and under spinal anesthesia. The patient will be hospitalized and must be discharged on the first postoperative day. After the procedure the patients will be under partial load as tolerated for two weeks with free range of motion and will start physiotherapy after 2 weeks of the procedure. During hospitalization the patient will receive analgesia with intravenous Dipirone 1g every 6 hours associated with Tramadol 100mg intravenously every 8 hours if severe pain. After discharge the patient will receive analgesia with dipyrone 1g orally every 6 hours associated with Tramadol 100mg orally every 8 hours if severe pain, and Tramadol used by the patient was quantified.

Patients will then be re-evaluated at 1, 3, 12, 24 and 48 weeks with the same previous criteria and at 12 months new MRI with the same previous protocol will be performed.

Conditions

• Bone Marrow Edema

Interventions

DEVICE

Percutaneous introduction of cannula

An 8 gauge cannula is introduced at the site of the bone marrow lesion. The introduction of the cannula is guided by fluoroscopy.

DIAGNOSTIC_TEST

Magnetic resonance imaging

MRI scans will be performed on a 1.5 T (Signa Excite HD, GE Healthcare, Waukesha, WI, USA) and a specific knee coil (HD TRKnee 8 Ch High Resolution Knee Array) will be used.

BIOLOGICAL

Bone Grafting

A bone substitute consisting of calcium phosphate will be injected through the cannula, previously inserted, filling the area of the bone marrow lesion. GRAFTYS HBS® (Graftys, Aix en Provence, France) will be used.

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Marco K Demange, PhD · Faculty

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-05

Primary Completion

2018-12-30

Completion

2018-12-30

Countries

• Brazil

Study Locations