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

NCT ID: NCT03699046

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2021-05-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Subchondroplasty and Knee Arthroscopy

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.

Group Type: ACTIVE_COMPARATOR

Subchondroplasty and Knee Arthroscopy

Intervention Type: PROCEDURE

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.

Subchondroplasty

Intervention Type: BIOLOGICAL

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).

Knee Arthroscopy Alone

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

Group Type: SHAM_COMPARATOR

Knee Arthroscopy Alone

Intervention Type: PROCEDURE

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.

Interventions

Subchondroplasty and Knee Arthroscopy

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

Knee Arthroscopy Alone

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: PROCEDURE

Subchondroplasty

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).

Intervention Type: BIOLOGICAL

Other Intervention Names

SCP® (Zimmer)

Eligibility Criteria

Inclusion Criteria

1. 40 years of age or older

2. Kellgren-Lawrence grade 1-3 osteoarthritis in the affected knee

3. Has experienced pain in the affected knee for at least 3 months

4. Candidate for knee arthroscopy (moderate to severe symptoms, lack of response to non-operative care, and/or mechanical symptoms)

5. Stable ligament exam

6. No additional injuries affecting the study knee or contralateral knee

7. Candidate for MRI (no pacemaker, aneurysmal clip, eye prosthesis, pregnancy, neurostimulator, implanted stimulator [e.g. diabetes pump])

8. Confirmed visualization of at least 1 bone marrow lesions using T2 weighted MRI

Exclusion Criteria

1. Determined to not be a surgical candidate

2. Kellgren-Lawrence grade 4 osteoarthritis

3. Unable to fit in XtremeCT scanner (based on measurement at time of recruitment)

4. Contraindications to MRI

5. Any hardware present in either knee that could interfere with MRI signal

6. Bone marrow lesion(s) caused by acute trauma prior to enrolment

7. Radiographic mal-alignment defined by obvious valgus > 7° or obvious varus > 7° on measured hip-knee-ankle angle

8. No bone marrow lesion detected on baseline (pre-operative) MRI

9. Rheumatoid arthritis

10. Septic arthritis

11. Reactive arthritis

12. Gout

13. Osteochondritis dissecans of knee resulting in significant bone loss

14. Collapse of subchondral bone

15. Restricted knee range of motion: passive flexion < 110° or a flexion contracture > 30°

16. Ligament instability in either knee

17. History of other arthropathies (e.g. sickle cell or autoimmune disease)

18. History of uncontrolled diabetes: HbA1C level of 8 or higher, measured within 3 months of enrollment

19. Unable to perform a functional assessment of either knee

20. Current smoker or stopped smoking for less than 3 months

21. History of invasive malignancy (Unless treated in the past and has had no clinical signs or symptoms of malignancy for 5 years or longer)

22. Has a primary bone tumor in the knee or adjacent to the knee

23. Having surgery on another part of the lower limb in addition to the study procedure

24. Taking prescription pain medication other than NSAIDs or acetominophen

25. Active infection or a history of joint infection

26. Pursuing action through the Workers' Compensation Board - Alberta

27. BMI > 40

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Alexander Rezansoff

Orthopaedic Surgeon and Clinical Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Rezansoff, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Denise Chan, MSc

Role: primary

kneeresearch@ucalgary.ca

403-220-8944

Other Identifiers

REB18-0650

Identifier Type: -

Identifier Source: org_study_id