Knee Osteoarthritis Clinical Trial
Official title:
Randomized Pilot Study Comparing the Effectiveness of Subchondroplasty Combined With Arthroscopy to Arthroscopy Alone for Treating Bone Marrow Lesions of the Knee
Verified date | March 2020 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | May 1, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | McCaig Institute for Bone and Joint Health - Centre for Mobility and Joint Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
Baseline (pre-surgery), 3 months, 6 months, 12 months, 24 months post-surgery. | |
Secondary | 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. |
Baseline (pre-surgery), 2 weeks, 3 months, 6 months, 12 months, 24 months post-surgery. | |
Secondary | 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. | Baseline (pre-surgery), 3 months, 12 months post-surgery | |
Secondary | 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. | Baseline (pre-surgery), 3 months, 12 months post-surgery | |
Secondary | 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. | Baseline (pre-surgery), 3 months, 12 months, 24 months post-surgery. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04651673 -
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
|
||
Completed |
NCT05677399 -
Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
|
N/A | |
Active, not recruiting |
NCT04043819 -
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
|
Phase 1 | |
Recruiting |
NCT06000410 -
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
|
Phase 3 | |
Completed |
NCT05014542 -
Needling Techniques for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05892133 -
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05528965 -
Parallel Versus Perpendicular Technique for Genicular Radiofrequency
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Active, not recruiting |
NCT02003976 -
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
|
N/A | |
Active, not recruiting |
NCT04017533 -
Stability of Uncemented Medially Stabilized TKA
|
N/A | |
Completed |
NCT04779164 -
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT04006314 -
Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05423587 -
Genicular Artery Embolisation for Knee Osteoarthritis II
|
N/A | |
Enrolling by invitation |
NCT04145401 -
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
|
||
Active, not recruiting |
NCT03781843 -
Effects of Genicular Nerve Block in Knee Osteoarthritis
|
N/A | |
Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05324163 -
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
|
Phase 3 | |
Completed |
NCT05529914 -
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05693493 -
Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?
|
N/A | |
Not yet recruiting |
NCT05510648 -
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
|
N/A |