FAQs | Oasis Trial

Enrollment FAQs

How many patients do we plan to enroll?

We aim to include 400 patients within the study.

Who can participate?

Military personnel and civilians between the ages of 17 and 50
Must have acute, traumatic anterior shoulder dislocation or instability associated with subcritical bone loss (10-20%) of the glenoid
Plan to return to demanding work or sports
Patients cannot have:
- Multidirectional instability
- Concomitant shoulder injuries including:
  - rotator cuff tears
  - motor nerve pathologies
  - osteoarthritis > S-P grade 2
- Neuromuscular or neurological disorders
  - including seizures
- History of shoulder surgery related to any intra-articular soft tissue, with the exception of a previous arthroscopic Bankart repair without remplissage
- Humeral sided bone lesion (Hill-Sachs lesion) that is large enough to render the lesion to be “off-track” even with a possible Latarjet procedure
- Have any issue with the contralateral shoulder that would preclude participation in research procedures
- Have any cartilage lesion in affected shoulder that would interfere with the course of care
- Have any relevant medical condition that would hinder study participation, including cognitive impairment/psychological concerns
- Known pregnancy at the time of imaging or surgery, as elective shoulder surgery is contraindicated.
- Have the absence of fixed address/no means of contact
- Known unavailability for follow-up commitments

What can be expected after surgery?

Post-Operative Rehabilitation:
- Rehabilitation for the first 12 weeks after surgery will be the same for all participants regardless of which surgery they have. The rehabilitation protocol has been developed to safely accommodate the slight variations in all three procedures and has been approved by the surgeon-investigators of this trial.
  - After 12 weeks, all rehabilitation programs will continue to be similar and will be based upon the results of interim testing at 3-, 4-, and 6-months during Research Follow-up visits. Therefore, each individual's rehabilitation may be somewhat different, but it will be specific to their deficits and goals.
  - At the 12- and 24-month standard-of-care clinical follow-up visits, participants will be assessed on their reported health assessments and will be monitored throughout their return to activity

How long will the study take?

Participants will be monitored for 24 months.

Are there any additional costs to participate in the study?

There are no additional costs to patients wishing to participate in the study. Participants and their insurance companies will not be billed for any testing that is performed during Research follow-up visits. Surgery costs, standard-of-care visits, and physical therapy will be billed to insurance plans accordingly, as would normally occur regardless of study participation.

General FAQs

Tell me about the difference between the three surgical procedures in terms of pain or discomfort after surgery.

Patients can expect similar levels of post-operative pain and discomfort after any of the three surgical interventions. In general, patients undergoing an open procedure, as opposed to an arthroscopic procedure, can anticipate slightly increased levels of pain due to the incision itself. However, any pain and discomfort after the surgery will be adequately managed by your surgeon.

Are all of the surgical procedures commonly used to treat patients with anterior shoulder instability?

Yes, all of the surgical procedures included in the study are commonly used to treat patients with anterior shoulder instability.

Is the type of surgery I undergo affected by my enrollment in the research study?

The type of surgery that you undergo has been selected by you and your surgeon, and it is not affected by your participation in this research study. Your surgeon will discuss each of these procedures and the risks involved with each. You are encouraged to ask questions. If you choose to provide consent, the researchers will follow your treatment throughout the 24 months following surgery. Your rehabilitation will be tailored to the surgical procedure you receive and is not affected by your participation in this research study.

Can any of the surgical procedures make my post-operative rehabilitation longer or harder or make a return to sports or work take more time?

All the surgical procedures used within the study have similar post-operative rehabilitation protocols and recovery times. Initially, patients will follow universal postoperative guidelines for the first 12 weeks. As the postoperative program progresses, patients will undergo similar rehabilitation protocols, with some modifications depending on identified deficits unique to each participant and their goals after surgery. It is estimated that it will take approximately 4-6 months to regain full use of your arm, similar to pre-injury use. However, return to pre-injury activity levels may take somewhat longer, but this is irrespective of which surgical procedure was undergone. As always, recovery is different for each patient. Your physical therapist and surgeon will be able to assess your condition periodically and decide how to safely progress with your rehabilitation program.

Is there a difference in surgery time between the three surgical procedures?

There is no difference in the duration of surgery, no matter which procedure is decided upon. The length of each surgical procedure is approximately 60-75 minutes.

How would I be treated if I DID NOT participate in the study?

If you choose not to provide your consent, you will not participate in the research study, and your surgery and rehabilitation will continue as scheduled. Whether or not you provide your consent for participation in this research study will have no effect on your current or future medical care at this hospital or with an affiliated healthcare provider. You may also discuss your care with another doctor who is not associated with this research study and are under no obligation to participate in any research study offered by your doctor.

If I participate, when will I have to complete standard-of-care activities, and when will I have to complete research-related activities?

You will complete standard-of-care clinical follow-ups with your surgeon at the following time points:

1-2 weeks after surgery
5- 8 weeks after surgery
3 months after surgery
4-6 months after surgery
12 months after surgery

Standard-of-care clinical visits will include a standard clinical assessment:

Pain levels
Pain medication you have used
Measuring range of motion
Identifying if any additional medical treatment was needed
Measuring muscle strength and motion
Reporting about what rehabilitation you are doing
Reporting on your activity level

You will complete full Research follow-ups, both in-person and by mail at the following time points:

In-person Research follow-ups will occur at:

3 months after randomization
4 months after randomization
6 months after randomization

All in-person research-related follow-ups should take approximately 40-50 minutes of your time.

You will complete brief remote Research follow-ups by e-mail, phone, or postal mail at the following time points:

Monthly from 3 to 11 months
Monthly from 3 to 13 months

Remote Research follow-ups should take approximately 10 to 15 minutes of your time.

When will I be compensated for my time? (e.g., following each data collection session; fixed time intervals; at the conclusion of the study)

Eligible participants, including non-active military personnel, will be compensated every time they complete the activities related to this research study. Active-duty personnel must be considered “off duty” to receive compensation. Compensation will be processed by your local research team and can be up to $440 for completing all research-related activities.

I am an active-duty Service Member, why cannot I be compensated for my participation in this study?

DoD regulations do not permit active-duty (“on duty” status) military personnel to be compensated for participation in research studies with the exception of blood draw studies. There is no blood draw associated with this study. Therefore, we are unable to provide compensation for active-duty military personnel, unless their status is “off duty”.

I no longer want to participate in this study, how do I notify the study team and what do I need to do to remove/cancel my consent to participate?

For you to formally withdraw from the research study you should provide a written and dated notice of this decision to your orthopedic surgeon at the address listed on the first page of the informed consent document you signed.