Comparison Of A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery

Sponsor
Orthopedic Institute, Sioux Falls, SD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05274737
Collaborator
(none)
40
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2
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Novel sling
  • Device: Traditional abduction sling
N/A

Detailed Description

Specific Aim I:

To determine if patients undergoing arthroscopic rotator cuff repair prefer the traditional abduction sling vs the novel sling.

Specific Aim II:

To determine if patients undergoing total shoulder arthroplasty prefer the traditional abduction sling vs the novel sling.

Specific Aim III:

To determine if short term follow-up (2, 4, 6 weeks), subjective patient-reported outcomes are superior in patients utilizing the novel sling compared to patients utilizing the traditional, abduction sling.

Specific Aim IV:

To determine if longer term follow-up (6 weeks, 14 weeks, 6 months, and 12 months), validated patient-reported outcomes are similar (non-inferior) in patients utilizing the novel sling compared to a historical control cohort of patients that only utilized the traditional, abduction sling. The purpose of this aim is to ensure that patients that utilize the novel novel sling for 2 to 4 weeks (with the traditional sling used for the rest of the 6 week period) do not have inferior outcomes compared to patients that have worn the traditional sling for a total of 6 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized, controlled modelRandomized, controlled model
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Trial Comparing A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Initial Immobilization with the novel sling

20 patients will be placed in the novel sling after surgery for the first two weeks. For the second two weeks (days 15-28) they will crossover and utilize the standard abduction sling. For the final two weeks (days 29-42) they will choose their preferred sling type and use it for the remainder of six week immobilization period.

Device: Novel sling
The novel sling was designed and created by the principal investigator to address these concerns of the traditional slings that are currently available for postsurgical protection and immobilization after shoulder surgery. It is anticipated that the novel sling will allow the patient to be more active and more comfortable while still providing a safe healing environment after a shoulder injury or shoulder surgery.

Experimental: Initial Postoperative Immobilization with the standard abduction sling

20 patients will be placed in the traditional abduction sling after surgery for the first two weeks. For the second two weeks (days 15-28) they will crossover and utilize the novel sling. For the final two weeks (days 29-42) they will choose their preferred sling type and use it for the remainder of six week immobilization period.

Device: Traditional abduction sling
An abduction sling is the most common type of sling utilized to protect patients after rotator cuff surgery and total shoulder of arthroplasty and can be considered the current standard of care.

Outcome Measures

Primary Outcome Measures

  1. Patient choice of type of sling to utilize from postoperative days 29-42 [6 weeks after surgery]

    Categorical variable of which sling they preferred to use for the last two weeks of their 6 week postoperative immobilization period

  2. Sling satisfaction survey [Prior to surgery]

    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

  3. Sling satisfaction survey [14 days after surgery]

    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

  4. Sling satisfaction survey [15 days after surgery]

    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.

  5. Sling satisfaction survey [28 days after surgery]

    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. Sling satisfaction survey [6 weeks after surgery]

    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

  7. Sling satisfaction survey [14 weeks after surgery]

    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

  8. Sling satisfaction survey [6 months after surgery]

    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

  9. Sling satisfaction survey [12 months after surgery]

    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

Secondary Outcome Measures

  1. American Shoulder and Elbow Surgeons Score [Prior to surgery]

    A validated joint specific patient-determined outcome score (low 0 - 100 high)

  2. American Shoulder and Elbow Surgeons Score [14 weeks after surgery]

    A validated joint specific patient-determined outcome score (low 0 - 100 high)

  3. American Shoulder and Elbow Surgeons Score [6 months after surgery]

    A validated joint specific patient-determined outcome score (low 0 - 100 high)

  4. American Shoulder and Elbow Surgeons Score [12 months after surgery]

    A validated joint specific patient-determined outcome score (low 0 - 100 high)

  5. Single Assessment Numeric Evaluation [Prior to surgery]

    A validated general patient-determined outcome score (low 0 - 100 high)

  6. Single Assessment Numeric Evaluation [6 weeks after surgery]

    A validated general patient-determined outcome score (low 0 - 100 high)

  7. Single Assessment Numeric Evaluation [14 weeks after surgery]

    A validated general patient-determined outcome score (low 0 - 100 high)

  8. Single Assessment Numeric Evaluation [6 months after surgery]

    A validated general patient-determined outcome score (low 0 - 100 high)

  9. Single Assessment Numeric Evaluation [12 months after surgery]

    A validated general patient-determined outcome score (low 0 - 100 high)

  10. Shoulder Activity Level [Prior to surgery]

    A validated shoulder-specific activity score (low 0 - 20 high)

  11. Shoulder Activity Level [14 weeks after surgery]

    A validated shoulder-specific activity score (low 0 - 20 high)

  12. Shoulder Activity Level [6 months after surgery]

    A validated shoulder-specific activity score (low 0 - 20 high)

  13. Shoulder Activity Level [12 months after surgery]

    A validated shoulder-specific activity score (low 0 - 20 high)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Orthopedic Institute Sioux Falls South Dakota United States 57117

Sponsors and Collaborators

  • Orthopedic Institute, Sioux Falls, SD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Keith Baumgarten, Principal Investigator, Orthopedic Institute, Sioux Falls, SD
ClinicalTrials.gov Identifier:
NCT05274737
Other Study ID Numbers:
  • Sling study
First Posted:
Mar 10, 2022
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Keith Baumgarten, Principal Investigator, Orthopedic Institute, Sioux Falls, SD
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2022