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

NCT03699046 | Unknown

• 1 other identifier: REB18-0650
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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; Knee Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

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

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

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

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

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

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

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

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

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

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

Study Arms (2)

Subchondroplasty and Knee Arthroscopy

ACTIVE COMPARATOR

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.

Procedure: Subchondroplasty and Knee Arthroscopy; Biological: Subchondroplasty

Knee Arthroscopy Alone

SHAM COMPARATOR

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

Procedure: Knee Arthroscopy Alone

Interventions

Subchondroplasty and Knee Arthroscopy 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 and Knee Arthroscopy

Knee Arthroscopy Alone 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.

Knee Arthroscopy Alone

Subchondroplasty 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).

Also known as: SCP® (Zimmer)

Subchondroplasty and Knee Arthroscopy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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°

Sponsors & Collaborators

• University of Calgary: lead
• McCaig Institute for Bone and Joint Health - Centre for Mobility and Joint Health: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Musculoskeletal Diseases

Interventions

Urocortins

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Alexander Rezansoff, MD, FRCSC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomized at the time of surgery to either the control group or the intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon and Clinical Lecturer

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

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: October 18, 2018
• Primary Completion: March 31, 2021
• Study Completion: May 1, 2021
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

CA (1)