Rotator Cuff TearNCT01333527
Early Mobilization Following Arthroscopic Rotator Cuff Repair
A study testing No Sling and Sling in people with Rotator Cuff Tear, run by University of Alberta at 1 site in Canada.
Trial summary
Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- No Sling and Sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to 2 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is over 18 years of age
- Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
- Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)
Who cannot join
- Patient has a full-thickness tear of the subscapularis and/or teres minor
- Patient has undergone previous RC surgery to the affected shoulder
- Patient has major joint trauma, infection, or avascular necrosis
- Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
- Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
- Patient has a psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
Show all 12Show fewer
- Patient has a major medical illness where life expectancy is less than 2 years
- Patient does not speak/read/understand English
- Patient has no fixed address or means of contact
- Surgeon or patient has decided to cancel surgery
- Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)
- Patient unwilling to complete necessary follow-ups
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation.
This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups:
Read more
Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only.
Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery.
Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.
- Conditions
- Rotator Cuff Tear
- Being tested
- No Sling, 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.
No SlingProcedure or surgery
Early range of motion
SlingProcedure or surgery
Patients will use the sling for 6 weeks, as per usual care
| Study group | Role | What they receive |
|---|---|---|
| Group A (early ROM) | Experimental | Group A (early ROM) will use the sling for comfort only Receives: Procedure: No Sling |
| Group B (usual care) | Active comparator | Group B (usual care) will be immobilized in a sling for 6 weeks. Receives: Procedure: Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff Index (WORC)
a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Range of Motion (ROM)
Measured flexion, abduction, external rotation in 90 degrees abduction [ER(90)], internal rotation in 90 degrees abduction [IR(90)], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Secondary outcomes (4)
Strength
strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT). Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion. External and internal rotation were measured in 90 degrees of abduction. Peak values were recorded during each contraction which was held for 3 seconds. Values were expressed as raw values.
Measured: Baseline, 6 months, 12 months, 24 months
The Short Form (36) Health Survey
The Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health. Each scale ranges between 0 (completely disable) to 100 (completely able).
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Adverse Events
The following complications were monitored throughout study:
- Medical related: urinary, gastrointestinal, cardiac, pulmonary, metabolic
- Surgical related: nerve injury, superficial or deep infection, dislocation, frozen shoulder, hematoma, biceps rupture, failure of tendon healing, dermatitis, reflex sympathetic dystrophy (RSD), persistent pain, re-injury.
- Other
The surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling).
Measured: 2 weeks, 6 weeks, 3 months, 6months
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)
Measured: baseline, 6 weeks, 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2015
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Sheps, MD,MSc,FRCSC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333527
- Sponsor's protocol ID
- RES0005824
- Status last verified
- Oct 2021
- First submitted
- 8 Apr 2011
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01333527
- Acronym / sponsor ID
- RES0005824
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation.
This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups:
Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only.
Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery.
Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (early ROM) | Experimental | Procedure: No SlingGroup A (early ROM) will use the sling for comfort only |
| Group B (usual care) | Active comparator | Procedure: SlingGroup B (usual care) will be immobilized in a sling for 6 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is over 18 years of age
- Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
- Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)
Key exclusion criteria (12 listed)
- Patient has a full-thickness tear of the subscapularis and/or teres minor
- Patient has undergone previous RC surgery to the affected shoulder
- Patient has major joint trauma, infection, or avascular necrosis
- Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
- Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
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 |
|---|---|---|
| No SlingEarly range of motion | Procedure or surgery | Group A (early ROM) |
| SlingPatients will use the sling for 6 weeks, as per usual care | Procedure or surgery | Group B (usual care) |
Primary outcome
Western Ontario Rotator Cuff Index (WORC)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best
Range of Motion (ROM)
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Measured flexion, abduction, external rotation in 90 degrees abduction [ER(90)], internal rotation in 90 degrees abduction [IR(90)], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout
4 secondary outcomes
Strength
Time frame: Baseline, 6 months, 12 months, 24 months
The Short Form (36) Health Survey
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Adverse Events
Time frame: 2 weeks, 6 weeks, 3 months, 6months
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Time frame: baseline, 6 weeks, 3, 6, 12, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Voll Non-Degradable Shoulder Spacer FIH Study
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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.
David Sheps, MD,MSc,FRCSC principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Sling and Sling in people with Rotator Cuff Tear, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 15 Oct 2021. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff Index (WORC) (time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months). The study lists 2 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 15 Oct 2021.