Full Thickness Rotator Cuff TearNCT02915588
Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair
A study testing early isometric loading after rotator cuff surgery and passive motion after rotator cuff surgery in people with Full Thickness Rotator Cuff Tear, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
The purpose of the study is to compare two different rehabilitation protocols after arthroscopic rotator cuff surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Full Thickness Rotator Cuff Tear
- What is being tested?
- early isometric loading after rotator cuff surgery and passive motion after rotator cuff surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2012to Dec 2013
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgery of the rotator cuff after full thickness tear
- informed consent
- understanding german language
Who cannot join
- previous surgery of the shoulder
- neurological or systemic diseases with impairment of shoulder function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Pilot Study
The purpose of the study is to compare two different rehabilitation protocols after arthroscopic rotator cuff surgery.
- Conditions
- Full Thickness Rotator Cuff Tear
- Being tested
- early isometric loading after rotator cuff surgery, passive motion after rotator cuff surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early isometric loading after rotator cuff surgeryOther
passive motion after rotator cuff surgeryOther
| Study group | Role | What they receive |
|---|---|---|
| Primary Active | Active comparator | Early postoperative isometric activation of the rotator cuff Receives: Other: early isometric loading after rotator cuff surgery |
| Primary Passive | Active comparator | Standard postoperative passive movement rehabilitation protocol Receives: Other: passive motion after rotator cuff surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Constant Murley Score
Timepoints: Before surgery; 6, 12, 24 weeks after surgery
Measured: up to 24 weeks
Secondary outcomes (4)
Change of DASH Score
Timepoints Before surgery; 6, 12, 24 weeks after surgery
Measured: up to 24 weeks
Change of Active range of Motion (Flexion, Extension, Abduction, Internal Rotation, External Rotation)
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Range of movement is measured by handheld goniometer
Measured: up to 24 weeks
Change of Pain (max; average; rest)
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Pain is measured by Visual Analogue Scale (0-100mm)
Measured: up to 24 weeks
Change of Strength (abduction; external Rotation)
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Measurement of Strength is evaluated using a BTE Simulator II Dynamometer (Peak torque in N).
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Thickness 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Mittermaier, Dr, Principal investigator, Institute of physical medicine and rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915588
- Sponsor's protocol ID
- PMR-Shoulder-001
- Status last verified
- Sep 2016
- First submitted
- 15 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02915588
- Acronym / sponsor ID
- PMR-Shoulder-001
- Conditions
- Full Thickness Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Sep 2016 (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 the study is to compare two different rehabilitation protocols after arthroscopic rotator cuff surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Active | Active comparator | Other: early isometric loading after rotator cuff surgeryEarly postoperative isometric activation of the rotator cuff |
| Primary Passive | Active comparator | Other: passive motion after rotator cuff surgeryStandard postoperative passive movement rehabilitation protocol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- surgery of the rotator cuff after full thickness tear
- informed consent
- understanding german language
Key exclusion criteria (2 listed)
- previous surgery of the shoulder
- neurological or systemic diseases with impairment of shoulder function
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 |
|---|---|---|
| early isometric loading after rotator cuff surgery | Other | Primary Active |
| passive motion after rotator cuff surgery | Other | Primary Passive |
Primary outcome
Change of Constant Murley Score
Time frame: up to 24 weeks
Timepoints: Before surgery; 6, 12, 24 weeks after surgery
4 secondary outcomes
Change of DASH Score
Time frame: up to 24 weeks
Change of Active range of Motion (Flexion, Extension, Abduction, Internal Rotation, External Rotation)
Time frame: up to 24 weeks
Change of Pain (max; average; rest)
Time frame: up to 24 weeks
Change of Strength (abduction; external Rotation)
Time frame: up to 24 weeks
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 27 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Christian Mittermaier, Dr principal investigator
Institute of physical medicine and rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early isometric loading after rotator cuff surgery and passive motion after rotator cuff surgery in people with Full Thickness Rotator Cuff Tear, run by Johannes Kepler University of Linz at 1 site in Austria.
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 2 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 27 Sep 2016. 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 Austria. 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?
Change of Constant Murley Score (time frame: up to 24 weeks). 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 27 Sep 2016.