Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133920
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-07-26
Brief Title:
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Sponsor:
The Cooper Health System
Organization:
The Cooper Health System
Study Overview
Official Title:
Immobilization Versus Early Range of Motion in Reverse Total Arthroplasty in Patients With Proximal Humerus Fractures
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate compare postoperative range of motion in patients who are given a sling for comfort only and allowed to start early active range of motion compared to patients who are placed in a sling for 4 weeks with passive range of motion only Once enrolled the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group
Detailed Description:
Reverse shoulder arthroplasty is often used for older patients with displaced proximal humerus fractures in the older patient population Many surgeons have historically placed patients in a sling for 4-6 weeks after surgery to prevent dislocation or tuberosity displacement More recently though surgeons are becoming more lenient with these restrictions as they realize it is very difficult for an elderly patient to be immobilized for 4-6 weeks There has been one randomized control trial looking at early range of motion versus immobilization for 6 weeks after a regular reverse total shoulder arthroplasty not done for fracture which showed no difference at one year There have not been any studies to date looking at reverse total shoulder arthroplasty for fracture to see if there is any difference in range of motion at early or later time points and also if there is an increased risk of complications
Preoperative visithospitalization The patient will be identified as meeting inclusion criteria and the study will be explained to them Patients will be given a consent form to review with adequate time to review and decide if they wish to participate If they choose to participate the patient will sign consent forms witnessed by personnel not associated with the study Patients will be randomized once consent has been obtained
The patient will then undergo surgery Operative data will be collected from their chart including implants used and intraoperative complications They will be placed in a sling if they are randomized to the sling group and given instructions on passive range of motion exercises to start postoperative day one If they are assigned to the early motion group they will be placed in a sling for comfort after surgery but told they can remove it when they feel their pain will allow They will also be instructed on the same passive range of motion program as the sling group This is different from the standard of care
Once enrolled the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group
They will undergo their reverse total shoulder arthroplasty for fracture as they will even if they do not agree to participate in the study normal treatment
The immobilization group will be placed in a shoulder abduction sling immediately after surgery for four weeks They will be allowed to start gentle passive range of motion with forward flexion to 120 degrees abduction to 90 degrees and external rotation to 30 degrees They will receive a home exercise program and formal physical therapy with these limits
When they come out of the sling at four weeks they will start active range of motion and active assisted range of motion They cannot internally rotate until 10 weeks after surgery No formal strengthening until 3 months after surgery
The early range of motion group will be given a sling for comfort after their surgery They will be told they can use their arm as tolerated and can remove the sling when comfortable immediately after surgery They will be allowed to start passive range of motion active assisted range of motion and gentle active range of motion with therapy as tolerated with the exception of no internal rotation They will also not be allowed to strengthen until 12 weeks after surgery They will get formal physical therapy and be given a home exercise program as well that will be directed by their physical therapist
Both groups will be evaluated postoperatively at 2 weeks 6 weeks 12 weeks 6 months 1 year and two years At each time point the following will be evaluated
Visual analog pain score American Shoulder and Elbow Society Scores Range of motion Complications Radiographs will be obtained at these visits
Thereported outcome scores will either be recorded in the office or via email using the surgical outcomes system database that is already approved for use at Cooper via legal for quality outcome measures The patient will be allowed to determine which method they would prefer and is easier for them
All of these visits will be the same as patients who choose not to enroll in the study No additional visits are required for the study The only differences in treatment will be obtaining the patient outcome scores listed above and the random assignment to one of two treatment groups The random treatment assignments are as follows the first group of patients will be placed in a sling for four weeks but with early stretching through physical therapy and the second group will be allowed to use the sling for comfort only and use their arm as tolerated for motion activities such as dressing and bathing The second group will also receive physical therapy
The results of the study will not be shared with the subjects or others unless they ask at the completion of the study at which point final data will be revealed to the subjects that ask
Preoperative visithospitalization The patient will be identified as meeting inclusion criteria and the study will be explained to them Patients will be given a consent form to review with adequate time to review and decide if they wish to participate If they choose to participate the patient will sign consent forms witnessed by personnel not associated with the study Patients will be randomized once consent has been obtained
The patient will then undergo surgery Operative data will be collected from their chart including implants used and intraoperative complications They will be placed in a sling if they are randomized to the sling group and given instructions on passive range of motion exercises to start postoperative day one If they are assigned to the early motion group they will be placed in a sling for comfort after surgery but told they can remove it when they feel their pain will allow They will also be instructed on the same passive range of motion program as the sling group This is different from the standard of care
Once enrolled the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group
They will undergo their reverse total shoulder arthroplasty for fracture as they will even if they do not agree to participate in the study normal treatment
The immobilization group will be placed in a shoulder abduction sling immediately after surgery for four weeks They will be allowed to start gentle passive range of motion with forward flexion to 120 degrees abduction to 90 degrees and external rotation to 30 degrees They will receive a home exercise program and formal physical therapy with these limits
When they come out of the sling at four weeks they will start active range of motion and active assisted range of motion They cannot internally rotate until 10 weeks after surgery No formal strengthening until 3 months after surgery
The early range of motion group will be given a sling for comfort after their surgery They will be told they can use their arm as tolerated and can remove the sling when comfortable immediately after surgery They will be allowed to start passive range of motion active assisted range of motion and gentle active range of motion with therapy as tolerated with the exception of no internal rotation They will also not be allowed to strengthen until 12 weeks after surgery They will get formal physical therapy and be given a home exercise program as well that will be directed by their physical therapist
Both groups will be evaluated postoperatively at 2 weeks 6 weeks 12 weeks 6 months 1 year and two years At each time point the following will be evaluated
Visual analog pain score American Shoulder and Elbow Society Scores Range of motion Complications Radiographs will be obtained at these visits
Thereported outcome scores will either be recorded in the office or via email using the surgical outcomes system database that is already approved for use at Cooper via legal for quality outcome measures The patient will be allowed to determine which method they would prefer and is easier for them
All of these visits will be the same as patients who choose not to enroll in the study No additional visits are required for the study The only differences in treatment will be obtaining the patient outcome scores listed above and the random assignment to one of two treatment groups The random treatment assignments are as follows the first group of patients will be placed in a sling for four weeks but with early stretching through physical therapy and the second group will be allowed to use the sling for comfort only and use their arm as tolerated for motion activities such as dressing and bathing The second group will also receive physical therapy
The results of the study will not be shared with the subjects or others unless they ask at the completion of the study at which point final data will be revealed to the subjects that ask
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None