When should the Surgery Report From be given to the physician?
The physician should receive the form either on the day of the surgery or the day after by one of the methods described below (see F3).
How soon does the Surgery Report Form need to be completed?
The Surgery Report Form should be completed within one week of the surgery date.
If an enrolled patient fails non-operative treatment, can they be scheduled for surgery?
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 [...]
Can the patient switch treatments after beginning the study?
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 [...]
What if a Worker’s Comp does not approve payment for a patient’s assigned treatment?
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 [...]
What if a patient’s insurance company limits the number of physical therapy visits it will cover?
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.
What if a patient begins their assigned treatment more than 2 months after randomization?
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.
How soon does the patient need to start their assigned treatment?
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 [...]
Can the patient use other treatments in conjunction with the assigned treatment?
Yes. Any other non-surgical treatments, such as cortisone injections, pain medications, acupuncture, etc., can be used while the patient undergoes the assigned treatment.