Rotator Cuff TearsNCT05274737
Comparison Of A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
A study testing Novel sling and Traditional abduction sling in people with Rotator Cuff Tears and Osteo Arthritis Shoulders, run by Orthopedic Institute, Sioux Falls, SD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears, Osteo Arthritis Shoulders
- What is being tested?
- Novel sling and Traditional abduction sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing arthroscopic rotator cuff repair and anatomic total shoulder arthroplasty
- Dominant extremity undergoing surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Khris Loe contact
United States1 site, 1 recruiting
- Recruiting
Orthopedic Institute
Sioux Falls, South Dakota, 57117
Keith M Baumgarten, MD, 605-331-5890
About this study
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.
Read the 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.
- Conditions
- Rotator Cuff Tears, Osteo Arthritis Shoulders
- Being tested
- Novel sling, Traditional abduction sling
- Keywords
- Shoulder, Sling
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel slingDevice
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.
Traditional abduction slingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Initial Immobilization with the novel sling | Experimental | 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. Receives: Device: Novel sling |
| Initial Postoperative Immobilization with the standard abduction sling | Experimental | 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. Receives: Device: Traditional abduction sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks after surgery
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
Measured: Prior to surgery
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
Measured: 14 days after surgery
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.
Measured: 15 days after surgery
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
Measured: 28 days after surgery
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
Measured: 6 weeks after surgery
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
Measured: 14 weeks after surgery
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
Measured: 6 months after surgery
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
Measured: 12 months after surgery
Secondary outcomes (13)
American Shoulder and Elbow Surgeons Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Measured: Prior to surgery
American Shoulder and Elbow Surgeons Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Measured: 14 weeks after surgery
American Shoulder and Elbow Surgeons Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Measured: 6 months after surgery
American Shoulder and Elbow Surgeons Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Measured: 12 months after surgery
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Measured: Prior to surgery
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Measured: 6 weeks after surgery
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Measured: 14 weeks after surgery
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Measured: 6 months after surgery
Single Assessment Numeric Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Measured: 12 months after surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Measured: Prior to surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Measured: 14 weeks after surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Measured: 6 months after surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Mar 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled model
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthopedic Institute, Sioux Falls, SD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Baumgarten, Orthopedic Institute, Sioux Falls, SD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274737
- Sponsor's protocol ID
- Sling study
- Status last verified
- Jun 2022
- First submitted
- 28 Feb 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there is not a plan to allow IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery
- ClinicalTrials.gov ID
- NCT05274737
- Acronym / sponsor ID
- Sling study
- Conditions
- Rotator Cuff Tears, Osteo Arthritis Shoulders
- Keywords
- Shoulder, Sling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Orthopedic Institute, Sioux Falls, SDUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled model
| Arm | Type | Receives |
|---|---|---|
| Initial Immobilization with the novel sling | Experimental | Device: Novel sling20 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. |
| Initial Postoperative Immobilization with the standard abduction sling | Experimental | Device: Traditional abduction sling20 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing arthroscopic rotator cuff repair and anatomic total shoulder arthroplasty
- Dominant extremity undergoing surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel slingThe 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. | Device | Initial Immobilization with the novel sling |
| Traditional abduction slingAn 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. | Device | Initial Postoperative Immobilization with the standard abduction sling |
Primary outcome
Patient choice of type of sling to utilize from postoperative days 29-42
Time frame: 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
Sling satisfaction survey
Time frame: 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
Sling satisfaction survey
Time frame: 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
Sling satisfaction survey
Time frame: 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.
Sling satisfaction survey
Time frame: 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
Sling satisfaction survey
Time frame: 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
Sling satisfaction survey
Time frame: 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
Sling satisfaction survey
Time frame: 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
Sling satisfaction survey
Time frame: 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
13 secondary outcomes
American Shoulder and Elbow Surgeons Score
Time frame: Prior to surgery
American Shoulder and Elbow Surgeons Score
Time frame: 14 weeks after surgery
American Shoulder and Elbow Surgeons Score
Time frame: 6 months after surgery
American Shoulder and Elbow Surgeons Score
Time frame: 12 months after surgery
Single Assessment Numeric Evaluation
Time frame: Prior to surgery
Single Assessment Numeric Evaluation
Time frame: 6 weeks after surgery
Single Assessment Numeric Evaluation
Time frame: 14 weeks after surgery
Single Assessment Numeric Evaluation
Time frame: 6 months after surgery
Single Assessment Numeric Evaluation
Time frame: 12 months after surgery
Shoulder Activity Level
Time frame: Prior to surgery
Shoulder Activity Level
Time frame: 14 weeks after surgery
Shoulder Activity Level
Time frame: 6 months after surgery
Shoulder Activity Level
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No. Currently there is not a plan to allow IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khris Loe contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel sling and Traditional abduction sling in people with Rotator Cuff Tears and Osteo Arthritis Shoulders, run by Orthopedic Institute, Sioux Falls, SD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith M Baumgarten, MD (605 339 6828, kbaumgarten@ortho-i.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient choice of type of sling to utilize from postoperative days 29-42 (time frame: 6 weeks after surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.