Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03699046
Status:
UNKNOWN
Last Update Posted:
2020-03-31
First Post:
2018-10-03
Brief Title:
Evaluating the Effectiveness of Subchondroplasty for Treating Bone Marrow Lesions of the Knee
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Randomized Pilot Study Comparing the Effectiveness of Subchondroplasty Combined With Arthroscopy to Arthroscopy Alone for Treating Bone Marrow Lesions of the Knee
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 qualitymicro-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
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 qualitymicro-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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None