Rotator Cuff TearNCT02059473
Treatment of Small Acute Cuff Tears, a Randomized Study
A study testing Rotator cuff repair and Physiotherapy in people with Rotator Cuff Tear, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Rotator cuff repair and Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to Nov 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Trauma to the shoulder
- Full thickness cranial rotator cuff tear
- Operation possible within 3 months
Who cannot join
- 2 or more rotator cuff tendons involved
- Fracture
- Dislocation
- Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor)
- Malignancy
- Rheumatic disease
- Inability to understand swedish
- Substance abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Orthopedic Clinic, Linköping University Hospital
Linköping, 58185
Hanna Hallgren, MD, +46 10 1037205, hanna.bjornsson.hallgren@lio.se
Mats Ranebo, MD, +46 480 81432, matsra@ltkalmar.se
About this study
Official title: Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial
The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.
Read the detailed description
In clinical practice most patients with a traumatic acute rotator cuff tear are treated with operative repair. The results of surgery are in most cases good but there are also good results in the literature from conservative treatment. So far there has been no prospective randomized comparison between the two treatments. When it comes to degenerative non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of surgery.
This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to surgery or physiotherapy. Surgical intervention is mini-open repair.
Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a blinded independent physiotherapist. At 12 months a new MRI is conducted as well.
- Conditions
- Rotator Cuff Tear
- Being tested
- Rotator cuff repair, Physiotherapy
- 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.
Rotator cuff repairProcedure or surgery
Physiotherapy \& Surgery
PhysiotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy & Surgery | Experimental | Mini-open rotator cuff repair Receives: Procedure: Rotator cuff repair; Procedure: Physiotherapy |
| Physiotherapy | Active comparator | Structured physiotherapy Receives: Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley Shoulder Assessment score
Measured: Twelve months
Secondary outcomes (2)
Western Ontario Rotator Cuff score
Shoulder specific, patient reported outcome score
Measured: Twelve months
MRI
Magnetic Resonance imaging. Gives a measure of muscle atrophy, fatty infiltration, rerupture and enlargement of the tendon rupture.
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Bjornsson, University Hospital, Linkoeping
- Investigators
- Lars Adolfsson, Professor, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059473
- Sponsor's protocol ID
- acutecufftearhannahallgren
- Status last verified
- Feb 2014
- First submitted
- 4 Feb 2014
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02059473
- Acronym / sponsor ID
- acutecufftearhannahallgren
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 11 Feb 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 purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.
Detailed description
In clinical practice most patients with a traumatic acute rotator cuff tear are treated with operative repair. The results of surgery are in most cases good but there are also good results in the literature from conservative treatment. So far there has been no prospective randomized comparison between the two treatments. When it comes to degenerative non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of surgery.
This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to surgery or physiotherapy. Surgical intervention is mini-open repair.
Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a blinded independent physiotherapist. At 12 months a new MRI is conducted as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy & Surgery | Experimental | Procedure: Rotator cuff repair, Procedure: PhysiotherapyMini-open rotator cuff repair |
| Physiotherapy | Active comparator | Procedure: PhysiotherapyStructured physiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Trauma to the shoulder
- Full thickness cranial rotator cuff tear
- Operation possible within 3 months
Key exclusion criteria (8 listed)
- 2 or more rotator cuff tendons involved
- Fracture
- Dislocation
- Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor)
- Malignancy
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 |
|---|---|---|
| Rotator cuff repairPhysiotherapy \& Surgery | Procedure or surgery | Physiotherapy & Surgery |
| Physiotherapy | Procedure or surgery | Physiotherapy, Physiotherapy & Surgery |
Primary outcome
Constant-Murley Shoulder Assessment score
Time frame: Twelve months
2 secondary outcomes
Western Ontario Rotator Cuff score
Time frame: Twelve months
MRI
Time frame: Twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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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.
Orthopedic Clinic, Linköping University Hospital
Linköping, Sweden
Lars Adolfsson, Professor principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator cuff repair and Physiotherapy in people with Rotator Cuff Tear, run by University Hospital, Linkoeping at 1 site in Sweden.
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 8 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 11 Feb 2014. 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 Sweden. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Shoulder Assessment score (time frame: Twelve months). 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 11 Feb 2014.