Rotator Cuff Tears Clinical Trial
Official title:
Randomized Trial Comparing A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
The objective of this study is to determine if the novel shoulder sling has higher patient satisfaction compared to a traditional, abduction sling with at least equivalent postoperative outcomes after arthroscopic rotator cuff repair and total shoulder arthroplasty.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 2024 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients undergoing arthroscopic rotator cuff repair and anatomic total shoulder arthroplasty - Dominant extremity undergoing surgery Exclusion Criteria: - Patients undergoing revision surgery - Patients with a history of significant cervical spine disease, peripheral neuropathy, or concomitant wrist or elbow disorders - Patients that do not understand English - Patients unwilling to participate or follow up for the study protocols |
Country | Name | City | State |
---|---|---|---|
United States | Orthopedic Institute | Sioux Falls | South Dakota |
Lead Sponsor | Collaborator |
---|---|
Orthopedic Institute, Sioux Falls, SD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient choice of type of sling to utilize from postoperative days 29-42 | Categorical variable of which sling they preferred to use for the last two weeks of their 6 week postoperative immobilization period | 6 weeks after surgery | |
Primary | Sling satisfaction survey | a novel, sling satisfaction score (SSS)[scale 0= best to 10=worst] utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use | Prior to surgery | |
Primary | Sling satisfaction survey | a novel, sling satisfaction score (SSS) [scale 0= best to 10=worst] utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use and satisfaction with the type of sling utilized during this time period | 14 days after surgery | |
Primary | Sling satisfaction survey | a novel, sling satisfaction score (SSS) [scale 0= best to 10=worst] utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use and satisfaction with the type of sling utilized during this time point. The rationale for recording both the day 14 and day 15 SSS is to get the patient's immediate impression on the potential subjective differences between the slings within 24 hours of changing to the alternate sling. | 15 days after surgery | |
Primary | Sling satisfaction survey | a novel, sling satisfaction score (SSS) [scale 0= best to 10=worst]utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use and satisfaction with the type of sling utilized during this time period | 28 days after surgery | |
Primary | Sling satisfaction survey | a novel, sling satisfaction score (SSS) [scale 0= best to 10=worst] utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use and satisfaction with the type of sling utilized during this time period | 6 weeks after surgery | |
Primary | Sling satisfaction survey | a novel, sling satisfaction score (SSS) [scale 0= best to 10=worst] utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use | 14 weeks after surgery | |
Primary | Sling satisfaction survey | a novel, sling satisfaction score (SSS) [scale 0= best to 10=worst] utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use | 6 months after surgery | |
Primary | Sling satisfaction survey | a novel, sling satisfaction score (SSS) [scale 0= best to 10=worst] utilizing a number-based visual analog scale will be utilized to assess baseline characteristics of common symptoms that have been attributed to sling use | 12 months after surgery | |
Secondary | American Shoulder and Elbow Surgeons Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | Prior to surgery | |
Secondary | American Shoulder and Elbow Surgeons Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 14 weeks after surgery | |
Secondary | American Shoulder and Elbow Surgeons Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 6 months after surgery | |
Secondary | American Shoulder and Elbow Surgeons Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 12 months after surgery | |
Secondary | Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | Prior to surgery | |
Secondary | Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 6 weeks after surgery | |
Secondary | Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 14 weeks after surgery | |
Secondary | Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 6 months after surgery | |
Secondary | Single Assessment Numeric Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 12 months after surgery | |
Secondary | Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | Prior to surgery | |
Secondary | Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 14 weeks after surgery | |
Secondary | Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 6 months after surgery | |
Secondary | Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 12 months after surgery |
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