NCT03941977

Brief Summary

Objective

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
Last Updated

May 20, 2019

Status Verified

April 1, 2019

Enrollment Period

4.2 years

First QC Date

February 20, 2017

Last Update Submit

May 16, 2019

Conditions

Bone Marrow Edema

Outcome Measures

Primary Outcomes (24)

  • Knee injury and Osteoarthritis Outcome Score

    Evatualion of Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life

    Pre-operative

  • Knee injury and Osteoarthritis Outcome Score

    Evatualion of Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life, comparative with pre-optative evaluation

    1 week postoperative

  • Knee injury and Osteoarthritis Outcome Score

    Evatualion of Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life, comparative with pre-optative evaluation

    3 weeks postoperative

  • Knee injury and Osteoarthritis Outcome Score

    Evatualion of Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life, comparative with pre-optative evaluation

    6 weeks postoperative

  • Knee injury and Osteoarthritis Outcome Score

    Evatualion of Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life, comparative with pre-optative evaluation

    12 weeks postoperative

  • Knee injury and Osteoarthritis Outcome Score

    Evatualion of Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life, comparative with pre-optative evaluation

    24 weeks postoperative

  • Knee injury and Osteoarthritis Outcome Score

    Evatualion of Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life, comparative with pre-optative evaluation

    48 weeks postoperative

  • International Knee Documentation Committee

    knee-specific patient-reported outcome measure

    Pre-operative

  • International Knee Documentation Committee

    knee-specific patient-reported outcome measure, comparative with pre-optative evaluation

    1 week postoperative

  • International Knee Documentation Committee

    knee-specific patient-reported outcome measure, comparative with pre-optative evaluation

    3 weeks postoperative

  • International Knee Documentation Committee

    knee-specific patient-reported outcome measure comparative with pre-optative evaluation

    6 weeks postoperative

  • International Knee Documentation Committee

    knee-specific patient-reported outcome measure, comparative with pre-optative evaluation

    12 weeks postoperative

  • International Knee Documentation Committee

    knee-specific patient-reported outcome measure, comparative with pre-optative evaluation

    24 weeks postoperative

  • International Knee Documentation Committee

    knee-specific patient-reported outcome measure, comparative with pre-optative evaluation

    48 weeks postoperative

  • Short Form 36 Health Survey

    Patient-reported survey of patient health

    Pre-operative

  • Short Form 36 Health Survey

    Patient-reported survey of patient health, comparative with pre-optative evaluation

    24 weeks postoperative

  • Short Form 36 Health Survey

    Patient-reported survey of patient health, comparative with pre-optative evaluation

    48 weeks postoperative

  • Visual analog scale for Pain

    Unidimensional measure of pain intensity

    Pre-operative

  • Visual analog scale for Pain

    Unidimensional measure of pain intensity, comparative with pre-optative evaluation

    1 Week postoperative

  • Visual analog scale for Pain

    Unidimensional measure of pain intensity, comparative with pre-optative evaluation

    3 weeks postoperative

  • Visual analog scale for Pain

    Unidimensional measure of pain intensity, comparative with pre-optative evaluation

    6 weeks postoperative

  • Visual analog scale for Pain

    Unidimensional measure of pain intensity, comparative with pre-optative evaluation

    12 weeks postoperative

  • Visual analog scale for Pain

    Unidimensional measure of pain intensity, comparative with pre-optative evaluation

    24 weeks postoperative

  • Visual analog scale for Pain

    Unidimensional measure of pain intensity, comparative with pre-optative evaluation

    48 weeks postoperative

Secondary Outcomes (1)

  • Edema Volume evaluation

    1 year postoperative

Study Arms (1)

Surgery

EXPERIMENTAL

Group evaluated with MRI and submitted to the percutaneous introduction of cannula for bone grafting

Device: Percutaneous introduction of cannulaDiagnostic Test: Magnetic resonance imagingBiological: Bone Grafting

Interventions

Percutaneous introduction of cannulaDEVICE

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

Also known as: Arm: Experimental: Surgery
Surgery
Magnetic resonance imagingDIAGNOSTIC_TEST

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.

Also known as: Arm: Experimental: Surgery
Surgery
Bone GraftingBIOLOGICAL

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.

Surgery

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 to 85 years
  • Gender: both genders
  • Knee pain for at least 6 months
  • Hypercaption lesion in subchondral region of tibial plateau or femoral condyle in T2-weighted magnetic resonance imaging with fat suppression.

You may not qualify if:

  • Rheumatologic diseases diagnosed in treatment
  • Renal insufficiency requiring hemodialysis
  • Not ambulatory
  • Knee osteoarthrosis with Kellegren / Lawrence classification greater than 3
  • Alignment in varus or valgus greater than 8 degrees in relation to the mechanical axis
  • Radiographic changes in the femoro-patellar joint associated with symptoms of anterior knee pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas - University of Sao Paulo

São Paulo, 05403-010, Brazil

Location

MeSH Terms

Interventions

Magnetic Resonance ImagingBone Transplantation

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Marco K Demange, PhD

    Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2017

First Posted

May 8, 2019

Study Start

November 5, 2014

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

May 20, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)