Rotator Cuff TearNCT01502098
Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair
A study testing Postoperative early passive motion and Sling in people with Rotator Cuff Tear, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Postoperative early passive motion and Sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteArgentina
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients skeletally mature (older 18 years old)
- Small or medium rupture of rotator cuff
- Repaired with arthroscopic double row technique
Who cannot join
- Impossibility to perform MRI (claustrophobic, pacemaker, heart or brain metallic implants)
- AC arthritis with mumford procedure
- Smokers
- Diabetes
- Postoperative complication (severe pain, thrombosis, infection)
- Psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, 1118
Juan Manuel Lopez Ovenza, MD, juanmanuel.lopez@hospitalitaliano.org.ar
About this study
Official title: Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.
The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.
- Conditions
- Rotator Cuff Tear
- Being tested
- Postoperative early passive motion, 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.
Postoperative early passive motionProcedure or surgery
Shoulder exercises starting on the first postoperative day
SlingOther
Sling for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Early passive motion | Active comparator | Pendulum exercises starting on the first postoperative day. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises were not permitted until four weeks after surgery. Receives: Procedure: Postoperative early passive motion |
| Immobilization | No intervention | Immobilization with sling during a month. Pendulum exercises starting on the fourth postoperative week. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises. Receives: Other: Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI
Measured: 6 months
Secondary outcomes (4)
ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale)
The ASES is 100-point standardized shoulder-assessment self-report form, 50 points of which are derived from patient self-report of pain on a visual analog scale and 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living derived using a four-point ordinal scale.
Measured: 1, 3, 6 months
Range of Motion
Measured: 1, 3, 6 months
VAS of pain
visual analogue scale of pain
Measured: 1, 3, 6 months
WORC
The Western Ontario Rotator Cuff Index (WORC) is a self-report questionnaire developed specifically to evaluate disability in persons with pathology of the rotator cuff of the shoulder.
Measured: 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (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
- Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lopez Ovenza Juan Manuel, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502098
- Sponsor's protocol ID
- CEPI:1780
- Status last verified
- Jan 2012
- First submitted
- 24 Dec 2011
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.
- ClinicalTrials.gov ID
- NCT01502098
- Acronym / sponsor ID
- CEPI:1780
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 30 Dec 2011 (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 aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early passive motion | Active comparator | Procedure: Postoperative early passive motionPendulum exercises starting on the first postoperative day. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises were not permitted until four weeks after surgery. |
| Immobilization | No intervention | Other: SlingImmobilization with sling during a month. Pendulum exercises starting on the fourth postoperative week. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients skeletally mature (older 18 years old)
- Small or medium rupture of rotator cuff
- Repaired with arthroscopic double row technique
Key exclusion criteria (6 listed)
- Impossibility to perform MRI (claustrophobic, pacemaker, heart or brain metallic implants)
- AC arthritis with mumford procedure
- Smokers
- Diabetes
- Postoperative complication (severe pain, thrombosis, infection)
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 |
|---|---|---|
| Postoperative early passive motionShoulder exercises starting on the first postoperative day | Procedure or surgery | Early passive motion |
| SlingSling for 4 weeks | Other | Immobilization |
Primary outcome
MRI
Time frame: 6 months
4 secondary outcomes
ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale)
Time frame: 1, 3, 6 months
Range of Motion
Time frame: 1, 3, 6 months
VAS of pain
Time frame: 1, 3, 6 months
WORC
Time frame: 1, 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative early passive motion and Sling in people with Rotator Cuff Tear, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 6 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 10 Jan 2012. 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 Argentina. 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?
Contact Juan M. Lopez Ovenza, MD (15-5-9249686, juanmanuel.lopez@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI (time frame: 6 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 10 Jan 2012.