NCT03941977

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

Completed NA Last updated 20 May 2019

What this trial tests

NA trial testing Percutaneous introduction of cannula in Bone Marrow Edema in 20 participants. Completed in 30 December 2018.

Timeline

5 November 2014

Primary endpoint
30 December 2018

30 December 2018

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	5 November 2014
Primary completion	30 December 2018
Estimated completion	30 December 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Percutaneous introduction of cannula
• Magnetic resonance imaging
• Bone Grafting — full drug profile →

Conditions studied

• Bone Marrow Edema — all drugs for Bone Marrow Edema →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 40 to 85, any sex, with Bone Marrow Edema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.