Bone Marrow EdemaNCT03941977
Treatment of Bone Marrow Edema Lesions of the Knee With Percutaneous Grafting
A study testing Percutaneous introduction of cannula, Magnetic resonance imaging and Bone Grafting in people with Bone Marrow Edema, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Bone Marrow Edema
- What is being tested?
- Percutaneous introduction of cannula, Magnetic resonance imaging and Bone Grafting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Nov 2014to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas - University of Sao Paulo
São Paulo, 05403-010
About this study
Objective
- To evaluate the technique of percutaneous grafting with bone substitute in the knee as to its applicability and technical feasibility.
- Evaluate the results regarding functional improvement and prevention of the evolution of joint cartilage degeneration.
Read more
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.
Read the detailed description
Initial assessment
All the patients included in the study were submitted to the initial evaluation, in which the following exams and scales were performed:
- Magnetic resonance of the affected knee, according to IOTHCFMUSP standard radiology protocol;
- Panoramic radiography of lower limbs to measure limb alignment;
- X-ray in antero-posterior incidence with load and knee profile;
- Functional ranges of subjective IKDC, KOOS and SF-36v1;
- Analog visual pain scale.
Radiographic evaluation and magnetic resonance imaging
The radiographs were evaluated and classified by a specialist radiologist in musculoskeletal, according to the Kellgren-Lawrence classification. The radiographs were not identified as to the moment of accomplishment, before or after the procedure. However, in many cases it was possible to identify signs of the procedure in the image, making the evaluator blind.
In the MRI images, the location of the bone edema was evaluated in relation to the affected bone (femur or tibia) and affected compartment (medial or lateral). The extent of edema divided into three levels according to the percentage of affected area of the coronal section of the femoral condyle or tibial plateau was also evaluated, with grade 1 being less than 25%, grade 2 between 25% and 50%, and grade 3 greater than 75 %. In the subchondral bone was also recorded the presence of fracture line, cysts and impactions / collapses of the articular surface. In the presence of impaction this was measured in millimeters.
Clinical and functional evaluation
The patients were evaluated by the functional scales: KOOS and subjective IKDC. Quality of life was also assessed by the SF-36v1 questionnaire.
Patient follow-up
Patients were followed in outpatient clinics at 1, 3, 6, 12, 24 and 48 weeks after the surgical procedure. Functional scales were repeated in all consultations. The quality of life scale was repeated at 24 and 48 weeks. Radiographs and MRI were repeated after 48 weeks of surgery.
Description of surgical technique
Magnetic resonance imaging of the patients was mapped in the surgical center to define the area of the lesion, as well as planning of the injection site at the center of the lesion, trajectory and cannula entry point. The cannula trajectory was defined by prioritizing an appropriate angle of attack for the entry point and larger distances of intraosseous trajectory, in order to avoid extravasation of the bone substitute through the cannula inlet.
The procedures were performed under spinal anesthesia, in a surgical center. The patients were placed in dorsal decubitus on a radiolucent table, with a cushion below the ipsilateral hip, for better control of the external rotation of the limb and a cushion also under the ipsilateral knee, aiding in the lateral incidence of fluoroscopy, avoiding the overlap of the knee image contralateral.
The material for the procedure was:
- An 8G metal cannula with distal and lateral exit orifice at the tip
- Metal cannula of the cannula with introductory tip with cut
- Metal cannula embolus with blunt tip
- High Flow Disposable Three-Way Infusion Faucet
- Five 1mL syringes with thread at the tip
- One syringe to prepare the Graftys HBS® bone substitute
According to preoperative planning, with the help of fluoroscopy in front and profile incidences, the cannula entry point was demarcated, with the placement of the cannula on the skin. Incisions of 5 mm in length were performed with a n11 scalpel blade at the point of entry into the skin. The cannulae were introduced, with fluoroscopy control, towards the center of the previously determined lesion. The progression was done manually or with the aid of hammer, when greater resistance was found.
During the introduction of the cannula, oblique incidences of fluoroscopy were performed to avoid perforation of the opposing cortex. The introduction of the cannula was performed very carefully when approaching the opposite cortical, with the possibility of using the blunt tip for cannula, making it difficult to perforation of the cortical.
The bone substitute was then prepared by mixing the solid content with the liquid to liquid / pasty state and transferred to 1 ml syringes. Transfer to smaller diameter syringes is important to achieve an injection flow with lower pressure application. The bone substitutes when subjected to higher pressures pass into a separation phase in which the liquid separates from the solid part, making it impossible to deliver the material in the desired area.
The 1 ml syringes were connected to the cannulae already positioned at the site determined for filling. The bone substitute was injected, interleaving the passage of a metal plunger through the cannula, between each syringe. Through the fluoroscopy it was possible to visualize the distribution of the product in the bone marrow, ensuring that the application was according to the mapping of the lesion and controlling the presence of possible extravasations. The amount of product injected was defined by the control of filling the area of the lesion by fluoroscopy. In cases of intra-articular extravasation, the injection was interrupted. After the injection was completed, it was waited 5 minutes before removal of the cannula, to reduce the reflux of the material through the inlet.
Post-operative care
The patients were hospitalized until the day after the procedure. Full load was allowed as tolerated for two weeks, with free range of motion. During hospitalization, patients received analgesia with intravenous dipyrone 1g every 6 hours, associated with intravenous tramadol 100mg every 8 hours if they presented severe pain greater than 7. After discharge, patients received analgesia with dipyrone 1g orally 6 in 6 hours, associated with tramadol 100mg orally every 8 hours, if severe pain, for a week, and the tramadol used by the patient in this period was quantified.
Surgical incision stitches were removed at the first outpatient appointment 1 week after surgery. The patients did not undergo physiotherapy or any type of rehabilitation after the procedure.
- Conditions
- Bone Marrow Edema
- Being tested
- Percutaneous introduction of cannula, Magnetic resonance imaging, Bone Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous introduction of cannulaDevice
Also called Arm: Experimental: Surgery
An 8 gauge cannula is introduced at the site of the bone marrow lesion. The introduction of the cannula is guided by fluoroscopy.
Magnetic resonance imagingDiagnostic test
Also called Arm: Experimental: Surgery
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Group evaluated with MRI and submitted to the percutaneous introduction of cannula for bone grafting Receives: Device: Percutaneous introduction of cannula; Diagnostic Test: Magnetic resonance imaging; Biological: Bone Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 weeks postoperative
International Knee Documentation Committee
knee-specific patient-reported outcome measure
Measured: Pre-operative
International Knee Documentation Committee
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
Measured: 1 week postoperative
International Knee Documentation Committee
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
Measured: 3 weeks postoperative
International Knee Documentation Committee
knee-specific patient-reported outcome measure comparative with pre-optative evaluation
Measured: 6 weeks postoperative
International Knee Documentation Committee
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
Measured: 12 weeks postoperative
International Knee Documentation Committee
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
Measured: 24 weeks postoperative
International Knee Documentation Committee
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
Measured: 48 weeks postoperative
Short Form 36 Health Survey
Patient-reported survey of patient health
Measured: Pre-operative
Short Form 36 Health Survey
Patient-reported survey of patient health, comparative with pre-optative evaluation
Measured: 24 weeks postoperative
Short Form 36 Health Survey
Patient-reported survey of patient health, comparative with pre-optative evaluation
Measured: 48 weeks postoperative
Visual analog scale for Pain
Unidimensional measure of pain intensity
Measured: Pre-operative
Visual analog scale for Pain
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Measured: 1 Week postoperative
Visual analog scale for Pain
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Measured: 3 weeks postoperative
Visual analog scale for Pain
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Measured: 6 weeks postoperative
Visual analog scale for Pain
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Measured: 12 weeks postoperative
Visual analog scale for Pain
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Measured: 24 weeks postoperative
Visual analog scale for Pain
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Measured: 48 weeks postoperative
Secondary outcomes (1)
Edema Volume evaluation
MRI evaluation
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start5 Nov 2014
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow EdemaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco K Demange, PhD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941977
- Sponsor's protocol ID
- 37392614.9.0000.0068
- Status last verified
- Apr 2019
- First submitted
- 20 Feb 2017
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bone Marrow Edema Lesions of the Knee With Percutaneous Grafting
- ClinicalTrials.gov ID
- NCT03941977
- Acronym / sponsor ID
- 37392614.9.0000.0068
- Conditions
- Bone Marrow Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective
- To evaluate the technique of percutaneous grafting with bone substitute in the knee as to its applicability and technical feasibility.
- 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.
Detailed description
Initial assessment
All the patients included in the study were submitted to the initial evaluation, in which the following exams and scales were performed:
- Magnetic resonance of the affected knee, according to IOTHCFMUSP standard radiology protocol;
- Panoramic radiography of lower limbs to measure limb alignment;
- X-ray in antero-posterior incidence with load and knee profile;
- Functional ranges of subjective IKDC, KOOS and SF-36v1;
- Analog visual pain scale.
Radiographic evaluation and magnetic resonance imaging
The radiographs were evaluated and classified by a specialist radiologist in musculoskeletal, according to the Kellgren-Lawrence classification. The radiographs were not identified as to the moment of accomplishment, before or after the procedure. However, in many cases it was possible to identify signs of the procedure in the image, making the evaluator blind.
In the MRI images, the location of the bone edema was evaluated in relation to the affected bone (femur or tibia) and affected compartment (medial or lateral). The extent of edema divided into three levels according to the percentage of affected area of the coronal section of the femoral condyle or tibial plateau was also evaluated, with grade 1 being less than 25%, grade 2 between 25% and 50%, and grade 3 greater than 75 %. In the subchondral bone was also recorded the presence of fracture line, cysts and impactions / collapses of the articular surface. In the presence of impaction this was measured in millimeters.
Clinical and functional evaluation
The patients were evaluated by the functional scales: KOOS and subjective IKDC. Quality of life was also assessed by the SF-36v1 questionnaire.
Patient follow-up
Patients were followed in outpatient clinics at 1, 3, 6, 12, 24 and 48 weeks after the surgical procedure. Functional scales were repeated in all consultations. The quality of life scale was repeated at 24 and 48 weeks. Radiographs and MRI were repeated after 48 weeks of surgery.
Description of surgical technique
Magnetic resonance imaging of the patients was mapped in the surgical center to define the area of the lesion, as well as planning of the injection site at the center of the lesion, trajectory and cannula entry point. The cannula trajectory was defined by prioritizing an appropriate angle of attack for the entry point and larger distances of intraosseous trajectory, in order to avoid extravasation of the bone substitute through the cannula inlet.
The procedures were performed under spinal anesthesia, in a surgical center. The patients were placed in dorsal decubitus on a radiolucent table, with a cushion below the ipsilateral hip, for better control of the external rotation of the limb and a cushion also under the ipsilateral knee, aiding in the lateral incidence of fluoroscopy, avoiding the overlap of the knee image contralateral.
The material for the procedure was:
- An 8G metal cannula with distal and lateral exit orifice at the tip
- Metal cannula of the cannula with introductory tip with cut
- Metal cannula embolus with blunt tip
- High Flow Disposable Three-Way Infusion Faucet
- Five 1mL syringes with thread at the tip
- One syringe to prepare the Graftys HBS® bone substitute
According to preoperative planning, with the help of fluoroscopy in front and profile incidences, the cannula entry point was demarcated, with the placement of the cannula on the skin. Incisions of 5 mm in length were performed with a n11 scalpel blade at the point of entry into the skin. The cannulae were introduced, with fluoroscopy control, towards the center of the previously determined lesion. The progression was done manually or with the aid of hammer, when greater resistance was found.
During the introduction of the cannula, oblique incidences of fluoroscopy were performed to avoid perforation of the opposing cortex. The introduction of the cannula was performed very carefully when approaching the opposite cortical, with the possibility of using the blunt tip for cannula, making it difficult to perforation of the cortical.
The bone substitute was then prepared by mixing the solid content with the liquid to liquid / pasty state and transferred to 1 ml syringes. Transfer to smaller diameter syringes is important to achieve an injection flow with lower pressure application. The bone substitutes when subjected to higher pressures pass into a separation phase in which the liquid separates from the solid part, making it impossible to deliver the material in the desired area.
The 1 ml syringes were connected to the cannulae already positioned at the site determined for filling. The bone substitute was injected, interleaving the passage of a metal plunger through the cannula, between each syringe. Through the fluoroscopy it was possible to visualize the distribution of the product in the bone marrow, ensuring that the application was according to the mapping of the lesion and controlling the presence of possible extravasations. The amount of product injected was defined by the control of filling the area of the lesion by fluoroscopy. In cases of intra-articular extravasation, the injection was interrupted. After the injection was completed, it was waited 5 minutes before removal of the cannula, to reduce the reflux of the material through the inlet.
Post-operative care
The patients were hospitalized until the day after the procedure. Full load was allowed as tolerated for two weeks, with free range of motion. During hospitalization, patients received analgesia with intravenous dipyrone 1g every 6 hours, associated with intravenous tramadol 100mg every 8 hours if they presented severe pain greater than 7. After discharge, patients received analgesia with dipyrone 1g orally 6 in 6 hours, associated with tramadol 100mg orally every 8 hours, if severe pain, for a week, and the tramadol used by the patient in this period was quantified.
Surgical incision stitches were removed at the first outpatient appointment 1 week after surgery. The patients did not undergo physiotherapy or any type of rehabilitation after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Device: Percutaneous introduction of cannula, Diagnostic Test: Magnetic resonance imaging, Biological: Bone GraftingGroup evaluated with MRI and submitted to the percutaneous introduction of cannula for bone grafting |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous introduction of cannulaAlso: Arm: Experimental: SurgeryAn 8 gauge cannula is introduced at the site of the bone marrow lesion. The introduction of the cannula is guided by fluoroscopy. | Device | Surgery |
| Magnetic resonance imagingAlso: Arm: Experimental: SurgeryMRI 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. | Diagnostic test | Surgery |
| Bone GraftingA 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. | Biological | Surgery |
Primary outcome
Knee injury and Osteoarthritis Outcome Score
Time frame: Pre-operative
Evatualion of Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life
Knee injury and Osteoarthritis Outcome Score
Time frame: 1 week postoperative
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
Knee injury and Osteoarthritis Outcome Score
Time frame: 3 weeks postoperative
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
Knee injury and Osteoarthritis Outcome Score
Time frame: 6 weeks postoperative
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
Knee injury and Osteoarthritis Outcome Score
Time frame: 12 weeks postoperative
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
Knee injury and Osteoarthritis Outcome Score
Time frame: 24 weeks postoperative
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
Knee injury and Osteoarthritis Outcome Score
Time frame: 48 weeks postoperative
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
International Knee Documentation Committee
Time frame: Pre-operative
knee-specific patient-reported outcome measure
International Knee Documentation Committee
Time frame: 1 week postoperative
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
International Knee Documentation Committee
Time frame: 3 weeks postoperative
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
International Knee Documentation Committee
Time frame: 6 weeks postoperative
knee-specific patient-reported outcome measure comparative with pre-optative evaluation
International Knee Documentation Committee
Time frame: 12 weeks postoperative
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
International Knee Documentation Committee
Time frame: 24 weeks postoperative
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
International Knee Documentation Committee
Time frame: 48 weeks postoperative
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
Short Form 36 Health Survey
Time frame: Pre-operative
Patient-reported survey of patient health
Short Form 36 Health Survey
Time frame: 24 weeks postoperative
Patient-reported survey of patient health, comparative with pre-optative evaluation
Short Form 36 Health Survey
Time frame: 48 weeks postoperative
Patient-reported survey of patient health, comparative with pre-optative evaluation
Visual analog scale for Pain
Time frame: Pre-operative
Unidimensional measure of pain intensity
Visual analog scale for Pain
Time frame: 1 Week postoperative
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Visual analog scale for Pain
Time frame: 3 weeks postoperative
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Visual analog scale for Pain
Time frame: 6 weeks postoperative
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Visual analog scale for Pain
Time frame: 12 weeks postoperative
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Visual analog scale for Pain
Time frame: 24 weeks postoperative
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
Visual analog scale for Pain
Time frame: 48 weeks postoperative
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
1 secondary outcome
Edema Volume evaluation
Time frame: 1 year postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Individual participant dataSharing planned: No
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco K Demange, PhD principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous introduction of cannula, Magnetic resonance imaging and Bone Grafting in people with Bone Marrow Edema, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (time frame: Pre-operative). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.