Rotator Cuff TearNCT01086202
Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty
An observational study of Rotator Cuff Tear and Proximal Humerus Fractures, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to prospectively evaluate two FDA approved implant designs for the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of offset each implant has. This offset may improve clinical outcomes in the patient population. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear, Proximal Humerus Fractures, Malunions
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2014
- Phase
- Observational
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly/aged, Inpatient and outpatient, healthy patients, females, males physically handicapped, Seventh-day Adventist cohort.
Who may be able to join
- 1. Any patient that is a candidate for reverse shoulder arthroplasty this includes:
- rotator cuff tear arthroplasty,
- irreparable rotator cuff tear,
- significant proximal humerus fracture and malunions,
- chronic proximal humerus dislocation.
Who cannot join
- Any patient with previous arthroplasty on affected shoulder.
- Patient who will need additional procedures including: bone grafting of the glenoid and muscle transfer.
- Patients who do not want to participate or participate in follow-ups.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health Care Dept. of Orthopaedic Surgery
Loma Linda, California, 92354
About this study
The purpose of this study is to prospectively evaluate two FDA approved implant designs for the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of offset each implant has. This offset may improve clinical outcomes in the patient population. There have been no clinical comparative studies between these two designs in the literature to date. We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.
Read the detailed description
The combination of shoulder arthritis and rotator cuff deficiency presents quite a surgical challenge. The reverse prosthesis offers a treatment option for subset of patients as previous attempts to treat with soft tissue reconstruction or conventional arthroplasty have provided sub-optimal clinical results. Numerous reports in the literature have validated the effectiveness of the reverse design.
Patients meeting criteria must be between the ages of 50 and 95 years of age and are a candidate for a reverse shoulder arthroplasty. This is includes patients with rotator cuff tear arthroplasty, irreparable rotator cuff tears, significant proximal humerus fractures and malunions, and chronic proximal humerus dislocators. A total of 40 patients will be enrolled and randomized to either one of two groups; 20 patients will be randomized to the Tornier Reversed shoulder Arthroplasty Medial offset, and 20 will receive the Lateral offset design. Both implants are FDA approved. The patients will be followed for 24 months and will follow-up will be at 6 weeks, 3 months, 6 months, 12 months and 24 months questionnaires will be completed at each visit, x-rays will be done at pre-op, 3 month, 6 months 12 and 24 months.
- Conditions
- Rotator Cuff Tear, Proximal Humerus Fractures, Malunions, Chronic Proximal Humerus Dislocations
- Keywords
- irreparable rotator cuff tears
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Tornier Reversed Shoulder Arthroplasty Medial Offset | Not described | |
| Lateral offset arthroplasty | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome Comparison Between Medical Lateral Offset Reverse Shoulder Arthroplasty
We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2014
- Study completionOct 2014
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesley P. Phipatanakul, Loma Linda University
- Investigators
- Wesley Phipatanakul, MD, Principal investigator, Loma Linda University Health Dept. Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086202
- Sponsor's protocol ID
- 59247
- Status last verified
- Jun 2011
- First submitted
- 11 Mar 2010
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT01086202
- Acronym / sponsor ID
- 59247
- Conditions
- Rotator Cuff Tear, Proximal Humerus Fractures, Malunions, Chronic Proximal Humerus Dislocations
- Keywords
- irreparable rotator cuff tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Mar 2010 (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 study is to prospectively evaluate two FDA approved implant designs for the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of offset each implant has. This offset may improve clinical outcomes in the patient population. There have been no clinical comparative studies between these two designs in the literature to date. We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.
Detailed description
The combination of shoulder arthritis and rotator cuff deficiency presents quite a surgical challenge. The reverse prosthesis offers a treatment option for subset of patients as previous attempts to treat with soft tissue reconstruction or conventional arthroplasty have provided sub-optimal clinical results. Numerous reports in the literature have validated the effectiveness of the reverse design.
Patients meeting criteria must be between the ages of 50 and 95 years of age and are a candidate for a reverse shoulder arthroplasty. This is includes patients with rotator cuff tear arthroplasty, irreparable rotator cuff tears, significant proximal humerus fractures and malunions, and chronic proximal humerus dislocators. A total of 40 patients will be enrolled and randomized to either one of two groups; 20 patients will be randomized to the Tornier Reversed shoulder Arthroplasty Medial offset, and 20 will receive the Lateral offset design. Both implants are FDA approved. The patients will be followed for 24 months and will follow-up will be at 6 weeks, 3 months, 6 months, 12 months and 24 months questionnaires will be completed at each visit, x-rays will be done at pre-op, 3 month, 6 months 12 and 24 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tornier Reversed Shoulder Arthroplasty Medial Offset | – | – |
| Lateral offset arthroplasty | – | – |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly/aged, Inpatient and outpatient, healthy patients, females, males physically handicapped, Seventh-day Adventist cohort.
Key inclusion criteria (5 listed)
- rotator cuff tear arthroplasty,
- irreparable rotator cuff tear,
- significant proximal humerus fracture and malunions,
- chronic proximal humerus dislocation.
Key exclusion criteria (3 listed)
- Any patient with previous arthroplasty on affected shoulder.
- Patient who will need additional procedures including: bone grafting of the glenoid and muscle transfer.
- Patients who do not want to participate or participate in follow-ups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Outcome Comparison Between Medical Lateral Offset Reverse Shoulder Arthroplasty
Time frame: 36 Months
We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.
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 15 Sep 2016.
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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.
Wesley Phipatanakul, MD principal investigator
Loma Linda University Health Dept. Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear and Proximal Humerus Fractures, run by Loma Linda University at 1 site in United States.
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 5 inclusion and 3 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 15 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 United States. 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?
Clinical Outcome Comparison Between Medical Lateral Offset Reverse Shoulder Arthroplasty (time frame: 36 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 15 Sep 2016.