AzTrials
AzTrials

Full Thickness Rotator Cuff TearsPhase 4NCT01741272

Early Mobilization Following Mini-Open Rotator Cuff Repair

A Phase 4 study testing Sling and No sling in people with Full Thickness Rotator Cuff Tears, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to determine if early active range of motion after mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6 weeks and 3 months after surgery. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Full Thickness Rotator Cuff Tears
What is being tested?
Sling and No sling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteCanada
Study dates
Sep 2003to Dec 2013
Phase
Phase 4
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

  • Clinical:
  • males and females over 18 years of age
  • failed non-operative management defined as persistent pain and/or disability following 3 months of conservative medical treatment including analgesic/anti-inflammatory medications, intra-articular corticosteroids, activity modification and physical therapy.
  • Radiological:
  • confirmed full-thickness rotator cuff tear on arthrogram or MRI
  • Surgical:
  • full-thickness tear of the rotator cuff confirmed through arthroscopy
  • rotator cuff repairable using mini-open approach

Who cannot join

  • previous shoulder surgery
  • previous fracture of scapula or humerus
  • history of charcot joint or inflammatory arthropathy
  • cervical radiculopathy
  • active joint or systemic infection
  • neurological disorder
Show all 12Show fewer
  • significant paralysis of the rotator cuff, deltoid or shoulder girdle musculature
  • major medical illness (life expectancy less than 2 years or unacceptably high operative risk)
  • unable to speak or read English
  • immunosuppressive therapy or chronic steroids (eg. prednisone)
  • patient unwilling to be followed for 2 years
  • psychiatric illness that precludes informed consent

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Grey Nuns Community Hospital

    Edmonton, Alberta, T6L 5X8

Other trials in Canada

About this study

Official title: Early Mobilization Following Mini-Open Rotator Cuff Repair: A Randomized Clinical Trial

The primary objective of this study is to determine if early active range of motion after mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6 weeks and 3 months after surgery. The secondary objective of this study is to determine if early mobilization improves disease-specific quality of life and promotes earlier return to work/function.

Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of range of motion, improved disease specific quality of life and earlier return to work/function if allowed to begin early active range of motion compared to subjects who are immobilized in a sling for 6 weeks.

Read the detailed description

The rotator cuff is a group of four muscles around the shoulder. They function to provide both shoulder mobility and power as well as stability. Rotator cuff tears can be a significant cause of pain and disability for the patient. Surgical repair is done to reconnect the torn tendon(s) to the bone and has been shown to be an effective treatment in the presence of full-thickness tears. The goals of Rotator Cuff (RC)surgery are to decrease pain, increase range of motion(ROM) and strength. This is done with a small incision called a mini-open. Standard care following this surgical repair is to be placed in a sling for 6 weeks to protect the repaired shoulder tendons. During this time ROM exercises are done using the non-operated arm for assistance. No active or voluntary movement is allowed during the first 6 weeks. Unfortunately, some of these patients develop shoulder stiffness which slows their recovery and return to work or daily activities and may result in increased use and cost of rehabilitation services.

The purpose of this study is to determine if following a RC repair, patients can safely stop wearing their sling and begin active ROM for activities of daily living as early as pain and comfort allow. A total of 190 patients have been recruited to this study (95/group) were randomly assigned to one of two study groups. Patients in Group A (sling for 6 weeks) will wear their sling for 6 weeks. Self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in Group B (Sling as needed) will be allowed to remove their sling as early as pain and comfort allow. Self-assisted ROM exercises are allowed at any time as are active ROM for activities of daily living. Patients who agree to participate will be seen by their surgeon and the research coordinator for a baseline assessment before surgery and again at 2 \& 6 weeks, 3, 6, 12 and 24 months after surgery. Each visit will include a ROM assessment and disease specific quality of life questionnaires. Patients will also undergo an Ultrasound exam at a minimum of 2 years after surgery to verify the integrity of their RC repair. Differences in ROM, questionnaire scores, RC integrity and adverse events will be examined between the two groups.

Being tested
Sling, No sling
Keywords
rotator cuff tear, arthroscopically assisted, health related quality of life(HRQL), functional outcome
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.

  • SlingProcedure or surgery

    Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.

  • No slingProcedure or surgery

    Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.

Study groups in NCT01741272
Study groupRoleWhat they receive
Group A (Usual Care)Active comparatorWill be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Receives: Procedure: Sling
Group B (Early ROM)ExperimentalWill use the sling for comfort only. Intervention: Procedure: No sling
Receives: Procedure: No sling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Range of Motion (ROM)From Baseline to 24 Months

    Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level).

    Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction.

    Measured: Baseline, 6 weeks, 3, 6, 12, 24 months

Secondary outcomes (4)

  1. Pain Questionnaire

    Shoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time.

    Measured: Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months

  2. WORC Questionnaire

    Health related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function.

    Measured: Baseline, 6, 12, 24 months

  3. Abduction Strength Using the Power Component of the Constant Score

    The Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25.

    Measured: Baseline, 24 months

  4. Complications

    Incidence of any surgical or medical complications will be prospectively documented.

    Measured: 2 & 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.

  1. First posted4 Dec 2012 (estimated)
  2. Study startSep 2003
  3. Primary completionJan 2013
  4. Study completionDec 2013

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741272
Sponsor's protocol ID
Pro00001096
Status last verified
Oct 2021
First submitted
29 Nov 2012
Last updated
28 Oct 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sling and No sling in people with Full Thickness Rotator Cuff Tears, 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 8 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 28 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2015). 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?

Change in Range of Motion (ROM)From Baseline to 24 Months (time frame: Baseline, 6 weeks, 3, 6, 12, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01741272.

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 28 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in