Subchondroplasty® Knee RCT (PRESERVE Knee)
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|ClinicalTrials.gov Identifier: NCT03112200|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : March 31, 2020
This is a multi-center, prospective, single-blinded, two-arm study, randomized to include 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone.
The primary objective of this study is to demonstrate superiority of Subchondroplasty with arthroscopy compared to arthroscopy alone for treatment of Bone Marrow Lesions (BMLs) in the knee.
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Edema Knee Pain Chronic Knee Osteoarthritis Osteoarthritis, Knee Osteoarthritis||Procedure: Subchondroplasty with Arthroscopy Procedure: Arthroscopy Alone||Not Applicable|
This is a multicenter, prospective, single-blinded, two-arm, randomized study. Enrolled subjects will have a single Bone Marrow Lesion of the tibia, single BML of the femur, or adjoining Bone Marrow Lesions of tibia and femur. Subjects will also be surgical candidates for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis.
A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be determined within study site and lesion polarity status (unipolar vs. bipolar).
Subjects will be enrolled within 60 days prior to surgery and take part in follow-up visits for two years following surgery. A preoperative visit will occur at the time of enrollment. Follow-up visits will occur at the study site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery. Telephone follow-up interviews will be done at 9 and 18 months post-surgery. Target enrollment is 201 subjects, to include 134 subjects in the treatment group (Subchondroplasty + Arthroscopy) and 67 subjects in the control group (Arthroscopy alone). Subjects will complete the study at the 24 month follow-up visit. For the purposes of this protocol, a revision will be defined as any partial or total joint arthroplasty or any bone fixation, bone grafting or bone substitute procedure in the same compartment in the study knee.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be determined within study site and lesion polarity status (unipolar vs. bipolar).|
|Masking Description:||The surgeon will be blinded to the treatment group until the time of surgery to avoid potential selection bias during the screening process. The subject will be blinded to the treatment group. The research coordinator will consult the central randomization list to determine which group the subject is in. Subjects may be randomized prior to surgery to allow for OR set-up. However, randomization should be performed as close to the time of surgery as possible to reduce the risk of randomization failures due to cancelled procedures.|
|Official Title:||A Randomized Controlled Trial of the Subchondroplasty® Procedure With Arthroscopy Versus Arthroscopy Alone for Treatment of Bone Marrow Lesions in the Knee|
|Actual Study Start Date :||March 29, 2017|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Active Comparator: Subchondroplasty with Arthroscopy
After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards.
Procedure: Subchondroplasty with Arthroscopy
The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
Sham Comparator: Arthroscopy Alone
After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion.
Procedure: Arthroscopy Alone
An endoscopic examination, therapy and surgery of the knee joint.
- Composite Clinical Success [ Time Frame: Superiority will be statistically tested at month 12 at p<0.01 ]
The primary objective of this study is to determine whether Subchondroplasty with arthroscopy is superior to arthroscopy alone for treatment of bone marrow lesions in the knee.
Superiority will be evaluated in terms of Composite Clinical Success (CCS) requiring freedom from subsequent secondary surgical intervention (SSSI) and among those free from SSSI, a clinically meaningful reduction in self-reported pain based on a validated measure of subject-reported pain (improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) pain of at least 10 points at 12 months) .
For the purpose of this study, SSSI will include any partial or total joint arthroplasty or any bone grafting or bone substitute procedure in the study knee.
- Change from baseline KOOS subscale scores at 12 Months [ Time Frame: 12 months post-surgery ]Comparison of mean change in KOOS subscale scores (Pain, Activities of Daily Living), Symptoms, Sports and Recreation, Quality of Life)
- Change from baseline Numeric Pain Score at 12 Months [ Time Frame: 12 months post-surgery ]Comparison of mean Numeric Pain Score
- Change from baseline EQ-5D score at 12 Months [ Time Frame: 12 months post-surgery ]Comparison of mean EQ-5D score
- Change from baseline Global Satisfaction score at 12 Months [ Time Frame: 12 months post-surgery ]Comparison of mean Global Satisfaction score
- Change from baseline x-rays to 12 Months [ Time Frame: 12 months post-surgery ]X-ray evaluation of joint space narrowing, osteophyte and cyst formation and subchondral sclerosis
- MRI analysis [ Time Frame: 12 months post-surgery ]MRI analysis of bone marrow lesion variables
- Incidence of post-operative complications and adverse events [ Time Frame: 12 months post-surgery ]Incidence of post-operative complications and adverse events
- Time to resolution of post-operative complications and adverse events [ Time Frame: 12 months post-surgery ]Time to resolution of post-operative complications and adverse events
- Incidence of joint injections [ Time Frame: 12 months post-surgery ]Incidence of joint injections
- Time to joint injections [ Time Frame: 12 months post-surgery ]Time to joint injections
- Incidence of re-operations and revisions [ Time Frame: 12 months post-surgery ]Incidence of re-operations and revisions
- Time to re-operations and revisions [ Time Frame: 12 months post-surgery ]Time to re-operations and revisions
- Healthcare utilization [ Time Frame: 12 months post-surgery ]Estimated total healthcare expenditure through 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112200
|Contact: Lynsey R Boyle, BSemail@example.com|
|Contact: Hillary Overholser, BSfirstname.lastname@example.org|
|Principal Investigator:||Jason Dragoo, MD||University of Colorado, Denver|