Protocol: A Randomized
Controlled Trial of the Subchondroplasty Procedure With
Arthroscopy Versus Arthroscopy Alone for Treatment of Bone Marrow
Lesions in the Knee.
The purpose of this study is to measure if there is an advantage of
the Subchondroplasty Procedure with arthroscopy compared to
arthroscopy alone in subjects with a bone marrow lesion (BML).
Determining if one procedure is better than the other will be measured
in terms of whether or not enrolled subjects require an additional
surgical intervention, after they have had the proposed procedure.
The PRESERVE - Knee Study is a clinical research study involving 201
patients with BML in the knee.
There will be two patient groups in this study. Study participants
will be randomly assigned to receive either the Subchondroplasty
procedure with arthroscopy (study group) or arthroscopy alone (control
group). Participants will be two times more likely to receive the
Subchondroplasty procedure with arthroscopy versus arthroscopy alone.
Enrolled patients will be asked to return to their doctor’s office
for five follow-up visits scheduled at 6 weeks, 3 months, 6 months, 12
months, and 24 months. Patients will complete questionnaires at each
of these visits which will ask for information about their pain,
function, and general health. Patients will also receive two follow-up
phone calls at 9 and 18 months to monitor their progress.
This study is currently active and open to enrollment.