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Evaluating the Effectiveness of Subchondroplasty for Treating Bone Marrow Lesions of the Knee

Primary Purpose

Osteoarthritis, Knee, Arthroscopy, Musculoskeletal Disease

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Subchondroplasty and Knee Arthroscopy

Knee Arthroscopy Alone

Subchondroplasty

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Bone Marrow Lesion, Subchondroplasty, Knee Function, Knee Pain, Bone Quality, Bone Micro-architecture

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

40 years of age or older
Kellgren-Lawrence grade 1-3 osteoarthritis in the affected knee
Has experienced pain in the affected knee for at least 3 months
Candidate for knee arthroscopy (moderate to severe symptoms, lack of response to non-operative care, and/or mechanical symptoms)
Stable ligament exam
No additional injuries affecting the study knee or contralateral knee
Candidate for MRI (no pacemaker, aneurysmal clip, eye prosthesis, pregnancy, neurostimulator, implanted stimulator [e.g. diabetes pump])
Confirmed visualization of at least 1 bone marrow lesions using T2 weighted MRI

Exclusion Criteria:

Determined to not be a surgical candidate
Kellgren-Lawrence grade 4 osteoarthritis
Unable to fit in XtremeCT scanner (based on measurement at time of recruitment)
Contraindications to MRI
Any hardware present in either knee that could interfere with MRI signal
Bone marrow lesion(s) caused by acute trauma prior to enrolment
Radiographic mal-alignment defined by obvious valgus > 7° or obvious varus > 7° on measured hip-knee-ankle angle
No bone marrow lesion detected on baseline (pre-operative) MRI
Rheumatoid arthritis
Septic arthritis
Reactive arthritis
Gout
Osteochondritis dissecans of knee resulting in significant bone loss
Collapse of subchondral bone
Restricted knee range of motion: passive flexion < 110° or a flexion contracture > 30°
Ligament instability in either knee
History of other arthropathies (e.g. sickle cell or autoimmune disease)
History of uncontrolled diabetes: HbA1C level of 8 or higher, measured within 3 months of enrollment
Unable to perform a functional assessment of either knee
Current smoker or stopped smoking for less than 3 months
History of invasive malignancy (Unless treated in the past and has had no clinical signs or symptoms of malignancy for 5 years or longer)
Has a primary bone tumor in the knee or adjacent to the knee
Having surgery on another part of the lower limb in addition to the study procedure
Taking prescription pain medication other than NSAIDs or acetominophen
Active infection or a history of joint infection
Pursuing action through the Workers' Compensation Board - Alberta
BMI > 40

Sites / Locations

University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Subchondroplasty and Knee Arthroscopy

Knee Arthroscopy Alone

Arm Description

Patients randomized to the Subchondroplasty and Knee Arthroscopy group will receive the subchondroplasty procedure before or after knee arthroscopy that will be completed based on current standard of care guidelines.

Patients randomized to the Knee Arthroscopy Alone group will receive the knee arthroscopy that will be completed based on current standard of care guidelines.

Outcomes

Primary Outcome Measures

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores

The primary outcome measure will be the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores for knee pain and knee function. The KOOS questionnaire consists of 5 different sub-scales including Symptoms (7 questions), Pain (9 questions), Activities of Daily Living (17 questions), Sports/Recreation (5 questions), and Quality of Life (4 questions). A normalized score from 0-100 (100 indicates no problems/symptoms and 0 indicates extreme problems/symptoms) is calculated for each sub-scale individually.

Secondary Outcome Measures

Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form scores

Knee pain and function will also be evaluated using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form scores. The IKDC includes three different domains including Symptoms (7 questions), Sports Activities (2 questions, 1 multi-part question), and Function (1 multi-part question). A total score from 0-100 (100 indicates no problems/symptoms and 0 indicates extreme problems/symptoms) is calculated.

Change in Patient-Reported Pain scores on the Visual Analog Scale (VAS)

Knee pain will also be evaluated using the Visual Analog Scale (VAS) scores for patient-reported pain. The Visual Analog Scale (VAS) consists of a 10 cm long straight line that starts from the lowest value of 0 (no pain) at one end, and the highest value of 10 (worst pain possible) at the other. Patients are asked to mark a place on the line that represents the severity of their pain. Scores are recorded in millimetres from 0-100 with 0 indicating no pain and 100 indicating the worst pain possible.

Change in bone quality/micro-architecture evaluated using magnetic resonance imaging (MRI)

The bone quality and micro-architecture of the bone marrow lesion(s) in the knee, and the knee overall, will be evaluated using magnetic resonance imaging (MRI). MRI will be used to identify the presence of bone marrow lesion(s) in the knee at baseline before surgery using a T2 weighted fat-suppression sequence and evaluate the bone marrow lesion(s) post-surgery.

Change in bone quality/micro-architecture evaluated using High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging

The bone quality and micro-architecture of the bone marrow lesion(s) in the knee, and the knee overall, will also be evaluated using High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging. HR-pQCT imaging will be used to evaluate the bone micro-architecture of the knee and the bone marrow lesion(s) before and after surgery.

Change in bone quality/micro-architecture evaluated using X-rays

The bone quality and micro-architecture of the bone marrow lesion(s) in the knee, and the knee overall, will also be evaluated using X-ray. X-ray imaging will be used to evaluate bone quality and osteoarthritis status before and after surgery.

Full Information

NCT ID

NCT03699046

First Posted

October 3, 2018

Last Updated

March 27, 2020

Sponsor

University of Calgary

Collaborators

McCaig Institute for Bone and Joint Health - Centre for Mobility and Joint Health

1. Study Identification

Unique Protocol Identification Number

NCT03699046

Brief Title

Evaluating the Effectiveness of Subchondroplasty for Treating Bone Marrow Lesions of the Knee

Official Title

Randomized Pilot Study Comparing the Effectiveness of Subchondroplasty Combined With Arthroscopy to Arthroscopy Alone for Treating Bone Marrow Lesions of the Knee

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 18, 2018 (Actual)

Primary Completion Date

March 31, 2021 (Anticipated)

Study Completion Date

May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

Collaborators

McCaig Institute for Bone and Joint Health - Centre for Mobility and Joint Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

The primary objective of this randomized pilot study is to evaluate whether subchondroplasty combined with knee arthroscopy is more effective at reducing knee pain and improving knee function compared to knee arthroscopy alone. All knee function outcomes will be assessed at initial presentation, 3 months, 6 months, 12 months, and 24 months following surgery using validated questionnaires. Patient-reported pain will also be recorded at 2 weeks after surgery. The secondary objective of the study is to determine whether the subchondroplasty and knee arthroscopy group has better bone quality and bone micro-architecture compared to the group receiving knee arthroscopy alone. Bone quality/micro-architecture will be evaluated at baseline, 3 months, and 12 months following surgery using Magnetic resonance imaging (MRI) and High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging and at baseline, 3 months, 12 months, and 24 months after surgery using X-rays.

Detailed Description

The investigators hypothesize that patients receiving subchondroplasty combined with arthroscopy will have reduced knee pain, improved knee function, and improved bone quality and micro-architecture compared to patients receiving arthroscopy alone who have symptomatic early osteoarthritis with the presence of at least one BML observed on MRI. Patients who provide informed consent to enroll in the study will be scheduled for knee surgery and randomized to receive subchondroplasty and arthroscopy or arthroscopy alone. Knee function outcomes will be assessed at initial presentation, 3 months, 6 months, 12 months, and 24 months following surgical intervention. Patient-reported pain will also be recorded at 2 weeks following surgical intervention. The evaluation of bone quality and micro-architecture will occur at baseline, 3 months, and 12 months following surgical intervention. X-rays will also be evaluated at the 24-month time-point.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Arthroscopy, Musculoskeletal Disease, Bone Marrow Edema, Subchondral Bone Edema, Knee Osteoarthritis

Keywords

Bone Marrow Lesion, Subchondroplasty, Knee Function, Knee Pain, Bone Quality, Bone Micro-architecture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The control group will be patients receiving knee arthroscopy alone and the intervention group will be patients receiving subchondroplasty and knee arthroscopy.

Masking

Participant

Masking Description

Patients will be randomized at the time of surgery to either the control group or the intervention group.

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Subchondroplasty and Knee Arthroscopy

Arm Type

Active Comparator

Arm Description

Arm Title

Knee Arthroscopy Alone

Arm Type

Sham Comparator

Arm Description

Patients randomized to the Knee Arthroscopy Alone group will receive the knee arthroscopy that will be completed based on current standard of care guidelines.

Intervention Type

Procedure

Intervention Name(s)

Subchondroplasty and Knee Arthroscopy

Intervention Description

Subchondroplasty® (SCP®) is a procedure performed along with minimally-invasive arthroscopy. The bone marrow lesion(s) will be located using pre-operative MRI combined with fluoroscopy (intra-operative X-ray) and a small, drillable AccuPort® Delivery Cannula will be placed in the appropriate position. The cannula will then be drilled into the bone marrow lesion(s) and a flowable, synthetic, calcium phosphate bone substitute (AccuFill® Bone Substitute Material, Zimmer Biomet) will be injected into the lesion(s). The calcium phosphate bone substitute will then harden, improve the structural integrity of the damaged subchondral bone, and will gradually be resorbed and replaced with new bone.

Intervention Type

Procedure

Intervention Name(s)

Knee Arthroscopy Alone

Intervention Description

Knee arthroscopy is a surgical procedure that involves the orthopaedic surgeon making small incisions in the knee and then inserting a small camera into the joint. Following the insertion of the camera, multiple procedures can be completed to treat a number of different conditions such as repair or partial/complete removal of the meniscus, debridement, lavage, removal of a loose body among others.

Intervention Type

Biological

Intervention Name(s)

Subchondroplasty

Other Intervention Name(s)

SCP® (Zimmer)

Intervention Description

Subchondroplasty® (SCP®) is a procedure performed along with minimally-invasive arthroscopy. The specific biological component of the procedure involves the injection of the AccuFill® Bone Substitute Material (Zimmer Biomet), which is a a flowable, synthetic, calcium phosphate bone substitute, into the bone marrow lesion(s).

Primary Outcome Measure Information:

Title

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores

Description

Time Frame

Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery.

Secondary Outcome Measure Information:

Title

Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form scores

Description

Time Frame

Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery.

Title

Change in Patient-Reported Pain scores on the Visual Analog Scale (VAS)

Description

Time Frame

Baseline (pre-surgery), 2 weeks, 3 months, 6 months, 12 months, 24 months post-surgery.

Title

Change in bone quality/micro-architecture evaluated using magnetic resonance imaging (MRI)

Description

Time Frame

Baseline (pre-surgery), 3 months, 12 months post-surgery

Title

Change in bone quality/micro-architecture evaluated using High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging

Description

Time Frame

Baseline (pre-surgery), 3 months, 12 months post-surgery

Title

Change in bone quality/micro-architecture evaluated using X-rays

Description

Time Frame

Baseline (pre-surgery), 3 months, 12 months, 24 months post-surgery.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 40 years of age or older Kellgren-Lawrence grade 1-3 osteoarthritis in the affected knee Has experienced pain in the affected knee for at least 3 months Candidate for knee arthroscopy (moderate to severe symptoms, lack of response to non-operative care, and/or mechanical symptoms) Stable ligament exam No additional injuries affecting the study knee or contralateral knee Candidate for MRI (no pacemaker, aneurysmal clip, eye prosthesis, pregnancy, neurostimulator, implanted stimulator [e.g. diabetes pump]) Confirmed visualization of at least 1 bone marrow lesions using T2 weighted MRI Exclusion Criteria: Determined to not be a surgical candidate Kellgren-Lawrence grade 4 osteoarthritis Unable to fit in XtremeCT scanner (based on measurement at time of recruitment) Contraindications to MRI Any hardware present in either knee that could interfere with MRI signal Bone marrow lesion(s) caused by acute trauma prior to enrolment Radiographic mal-alignment defined by obvious valgus > 7° or obvious varus > 7° on measured hip-knee-ankle angle No bone marrow lesion detected on baseline (pre-operative) MRI Rheumatoid arthritis Septic arthritis Reactive arthritis Gout Osteochondritis dissecans of knee resulting in significant bone loss Collapse of subchondral bone Restricted knee range of motion: passive flexion < 110° or a flexion contracture > 30° Ligament instability in either knee History of other arthropathies (e.g. sickle cell or autoimmune disease) History of uncontrolled diabetes: HbA1C level of 8 or higher, measured within 3 months of enrollment Unable to perform a functional assessment of either knee Current smoker or stopped smoking for less than 3 months History of invasive malignancy (Unless treated in the past and has had no clinical signs or symptoms of malignancy for 5 years or longer) Has a primary bone tumor in the knee or adjacent to the knee Having surgery on another part of the lower limb in addition to the study procedure Taking prescription pain medication other than NSAIDs or acetominophen Active infection or a history of joint infection Pursuing action through the Workers' Compensation Board - Alberta BMI > 40

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Rezansoff, MD, FRCSC

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 1N4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Denise Chan, MSc

Phone

403-220-8944

kneeresearch@ucalgary.ca

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Effectiveness of Subchondroplasty for Treating Bone Marrow Lesions of the Knee

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