Yes. Appropriate follow-up care and treatment should be provided based on each individual patient’s needs and the determination of their treating physician. Ideally, patients randomized to non-operative treatment should wait 6 months before pursuing surgery, if possible, in order for the treatment to be fully effective. However, if, prior to the 6-month mark, the physician [...]
Yes. The patient is free to switch treatments at any time. However, ideally, patients are asked to stick with their assigned treatment for at least 6 months. If there are a significant number of patients who “cross over” within the first 6 months – operative patients who do not have surgery or nonoperative patients who [...]
The patient would remain in the study and continue to be followed. Depending on the particular circumstances and their treatment assignment, the patient may become a “crossover” and/or may generate a protocol deviation (if treatment is not started with 2 months of randomization).
What happens if a patient’s insurance company refuses to pay for surgery AFTER they have been randomized to the operative arm?
The study does not cover the cost of treatment, so the surgery would likely not be performed and this patient would become a “crossover.” While every effort should be made to avoid randomizing a patient whose insurance will not pay for treatment, once randomized – regardless of whether the assigned treatment is completed – a [...]
There is a lot of flexibility in the physical therapy treatment protocols (for both postop & non-op) regarding how often a patient attends physical therapy. In consultation with their treating physical therapist, patients can customize the ratio of in-clinic physical therapy visits to home exercise days to fit their individual needs, schedule, and insurance coverage.
That patient would continue in the study as normal and complete all follow-up questionnaires as usual. However, the late start of treatment would be recorded as a protocol deviation.
Ideally, patients should begin treatment as soon as possible, but – at most – they should begin their assigned treatment within 2 months (8 weeks) after randomization. If a patient cannot begin treatment within 2 months, they could wait to enroll in the trial until they can begin treatment. Otherwise, it would be a protocol [...]
Yes. Any other non-surgical treatments, such as cortisone injections, pain medications, acupuncture, etc., can be used while the patient undergoes the assigned treatment.
Yes. The patient can do physical therapy with the physical therapist of their choice. For patients who simply cannot or do not want to travel to the recruiting site, you can help refer them to a clinic near them that is part of our study physical therapy network (found on study website). The advantage here [...]