Recruiting

Subchondroplasty

Sponsor:

University of Calgary

Code:

NCT03699046

Conditions

Osteoarthritis, Knee

Arthroscopy

Musculoskeletal Disease

Bone Marrow Edema

Subchondral Bone Edema

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Subchondroplasty and Knee Arthroscopy

Knee Arthroscopy Alone

Subchondroplasty

Study Details

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.

Conditions

Osteoarthritis, Knee

Arthroscopy

Musculoskeletal Disease

Bone Marrow Edema

Subchondral Bone Edema

Study ID

NCT03699046

Start date

Oct 18, 2018

Status verified date

Mar, 2020

Completion date

May 1, 2021

Anticipated

Primary completion date

Mar 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

sham comparator: 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.

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.

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.

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).

Primary outcome measure

  • Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores [ Time Frame: Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery. ]

Central Contacts and Locations

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Denise Chan, MSc

403-220-8944kneeresearch@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Mar 31, 2020

Last verified

Mar, 2020

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2020-03-31.