Rotator Cuff RuptureNCT02050087
The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair
A study testing Simple sling. and Neutral brace in people with Rotator Cuff Rupture, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Rupture
- What is being tested?
- Simple sling. and Neutral brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2013to Jan 2017
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon -
Exclusion Criteria: Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon.
Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration >grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-inferiority Trial
The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.
Read the detailed description
Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.
- Conditions
- Rotator Cuff Rupture
- Being tested
- Simple sling., Neutral brace
- Keywords
- Rotator cuff, Rehabilitation
- 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.
Simple sling.Device
Neutral braceDevice
| Study group | Role | What they receive |
|---|---|---|
| 3 weeks with simple sling | Active comparator | Early motion after arthroscopic rotator cuff repair. Receives: Device: Neutral brace |
| 6 weeks with neutral brace | Active comparator | Delayed motion after arthroscopic rotator cuff repair. Receives: Device: Simple sling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint
We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff RuptureStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sigbjørn Dimmen, MD, Phd, Study chair, Lovisenberg Diaconal Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050087
- Sponsor's protocol ID
- 2012/2288
- Status last verified
- May 2017
- First submitted
- 28 Jan 2014
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02050087
- Acronym / sponsor ID
- 2012/2288
- Conditions
- Rotator Cuff Rupture
- Keywords
- Rotator cuff, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Jan 2014 (estimated)
- 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 study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.
Detailed description
Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 weeks with simple sling | Active comparator | Device: Neutral braceEarly motion after arthroscopic rotator cuff repair. |
| 6 weeks with neutral brace | Active comparator | Device: Simple sling.Delayed motion after arthroscopic rotator cuff repair. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Simple sling. | Device | 6 weeks with neutral brace |
| Neutral brace | Device | 3 weeks with simple sling |
Primary outcome
We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint
Time frame: One year
We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
Related trials for Rotator Cuff Rupture
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
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.
Sigbjørn Dimmen, MD, Phd study chair
Lovisenberg Diaconal Hospital, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple sling. and Neutral brace in people with Rotator Cuff Rupture, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint (time frame: One year). 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 31 May 2017.