Randomized Pilot Study Comparing the Effectiveness of Subchondroplasty Combined With Arthroscopy to Arthroscopy Alone for Treating Bone Marrow Lesions of the Knee
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients will be randomized at the time of surgery to either the control group or the intervention group.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Subchondroplasty and Knee Arthroscopy (Procedure)
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.
干预措施: Subchondroplasty (Biological)
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.
干预措施: Knee Arthroscopy Alone (Procedure)
结局指标
主要结局
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores
时间窗: Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery.
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.
次要结局
- 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.)
研究者
Alexander Rezansoff
Orthopaedic Surgeon and Clinical Lecturer
University of Calgary