Shoulder DiseaseNCT03956316
Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System
An observational study of Shoulder Disease, run by OrthoIndy.
Trial summary
The goals of total, reverse total and hemi shoulder arthroplasty are the same, to alleviate the patient's pain and obtain a full functional recovery. This outcome depends on the surgeon's ability to reproduce normal glenohumeral anatomy including bone morphology, capsular tension and rotator cuff function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Disease
- What is being tested?
- Titan Modular Total Shoulder System
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2014to 22 Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 39 subjects received total shoulder arthroplasty using the Titan Modular Total Shoulder System. 25 subjects agreed to participate in the study.
Who may be able to join
- Total shoulder arthroplasty using the Titan Modular Total Shoulder System
Who cannot join
- Declining to participate
About this study
The goals of total, reverse total and hemi shoulder arthroplasty are the same, to alleviate the patient's pain and obtain a full functional recovery. This outcome depends on the surgeon's ability to reproduce normal glenohumeral anatomy including bone morphology, capsular tension and rotator cuff function. Shoulder arthroplasty has become a safe and effective treatment for various diseases of the shoulder. This study goal is to document and report the short-term functional, radiographic, and quality of life outcomes of total shoulder arthroplasty (TSA) using the titan modular shoulder system.
- Conditions
- Shoulder Disease
- Being tested
- Titan Modular Total Shoulder System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titan Modular Total Shoulder SystemDevice
total shoulder arthroplasty using the Titan Modular Total Shoulder System
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES
- ASES: the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment
- The ASES scale is intended to measure functional limitations and pain of the shoulder.
- ASES is a 0 - 100 point scale; higher scores indicate better outcomes.
- The ASES consists of two dimensions: pain and function (worth 50 points each).
- The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. Patient questions focus on: joint pain, instability and activities of daily living. Physician questions focus on: range of motion, strength, signs and instability
Measured: two year post op
EQ-5D-5L
- EQ5D-5L: EuroQuol-5D
- The EQ5D-5L scale evaluates general health status. The EQ-5D-5L has two sections; the first section measures health status using a descriptive system (index of 5 scores) and the second section measures health status on a Visual Analog Scale.
- The EQ-5D-5L VAS outcome is measured on a 0 - 100 point scale. Optimal health status is indicated with a score of 100. ii. The EQ-5D-5L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is evaluated with a score of 1-5, higher scores indicate worse outcomes.
- On each dimension, a score of 1 indicates no patient problems in that dimension, 2 indicates slight problems in that dimension, 3 indicates moderate problems in that dimension, 4 indicates severe problems in that dimension and 5 indicates extreme problems in that dimension.
Measured: two year post op
PENN
- PENN: PENN Shoulder Score
- The PENN Shoulder Score is used to assess patient self-reported levels of pain, satisfaction and function.
- PENN is measured on a 0 - 100 point scale; higher scores indicate better outcomes.
- The PENN consists of 3 subscales: pain (at rest, with activity, and with strenuous activity), satisfaction and function. The PENN Pain subscale is scored from 0 to 30, the PENN satisfaction subscale is scored from 0 to 10 and the PENN function subscale is scored from 0 to 60.
Measured: two year post op
SANE
- SANE: Single assessment numeric evaluation
- SANE is an outcome scale used to record the patient's self-reported function.
- SANE is implemented on a scale of 0 - 100, 100 indicates full function (or function prior to injury) and 0 represents no function.
Measured: two year post op
CS
- CS: Constant-Murley Score
- The CS score assesses functionality after the treatment of a shoulder injury.
- CS is measured on a 0 - 100 point scale. Higher scores indicate better shoulder function.
- CS is composed of four subscales: pain (15 points, based on patient report), activities of daily living (20 points, based on patient report), strength (25 points), and range of motion (40 points).
Measured: two year post op
WOOS
- WOOS: Western Ontario Osteoarthritis of the Shoulder index
- WOOS is a disease-specific quality of life PRO tool, developed for osteoarthritis.
- WOOS is measured on a 0-1900 point scale; 1900 indicates a clinical outcome fully symptomatic of osteoarthritis and 0 indicates an asymptomatic outcome.
- WOOS is composed of 19 items scored on 100-point VAS scales. The 19 items represent four domains (6 questions for pain and physical symptoms, 5 questions for sport/recreation/work function, 5 questions for lifestyle function and 3 questions for emotional function).
Measured: two year post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start15 Oct 2014
- Primary completion22 Dec 2015
- Study completion22 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoIndy
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Principal investigator, Troy Roberson, MD, OrthoIndy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956316
- Sponsor's protocol ID
- Integra TSA
- Status last verified
- May 2019
- First submitted
- 10 Apr 2019
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System
- ClinicalTrials.gov ID
- NCT03956316
- Acronym / sponsor ID
- Integra TSA
- Conditions
- Shoulder Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- OrthoIndyUniversity, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 22 Dec 2015 (actual)
- Study completion
- 22 Dec 2015 (actual)
- First posted
- 20 May 2019 (actual)
- 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 goals of total, reverse total and hemi shoulder arthroplasty are the same, to alleviate the patient's pain and obtain a full functional recovery. This outcome depends on the surgeon's ability to reproduce normal glenohumeral anatomy including bone morphology, capsular tension and rotator cuff function. Shoulder arthroplasty has become a safe and effective treatment for various diseases of the shoulder. This study goal is to document and report the short-term functional, radiographic, and quality of life outcomes of total shoulder arthroplasty (TSA) using the titan modular shoulder system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 39 subjects received total shoulder arthroplasty using the Titan Modular Total Shoulder System. 25 subjects agreed to participate in the study.
Key inclusion criteria (1 listed)
- Total shoulder arthroplasty using the Titan Modular Total Shoulder System
Key exclusion criteria (1 listed)
- Declining to participate
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 |
|---|---|---|
| Titan Modular Total Shoulder Systemtotal shoulder arthroplasty using the Titan Modular Total Shoulder System | Device | – |
Primary outcome
ASES
Time frame: two year post op
1. ASES: the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment 1. The ASES scale is intended to measure functional limitations and pain of the shoulder. 2. ASES is a 0 - 100 point scale; higher scores indicate better outcomes. i. The ASES consists of two dimensions: pain and function (worth 50 points each). a. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. Patient questions focus on: joint pain, instability and activities of daily living. Physician questions focus on: range of motion, strength, signs and instability
EQ-5D-5L
Time frame: two year post op
2. EQ5D-5L: EuroQuol-5D a. The EQ5D-5L scale evaluates general health status. The EQ-5D-5L has two sections; the first section measures health status using a descriptive system (index of 5 scores) and the second section measures health status on a Visual Analog Scale. i. The EQ-5D-5L VAS outcome is measured on a 0 - 100 point scale. Optimal health status is indicated with a score of 100. ii. The EQ-5D-5L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is evaluated with a score of 1-5, higher scores indicate worse outcomes. 1. On each dimension, a score of 1 indicates no patient problems in that dimension, 2 indicates slight problems in that dimension, 3 indicates moderate problems in that dimension, 4 indicates severe problems in that dimension and 5 indicates extreme problems in that dimension.
PENN
Time frame: two year post op
3. PENN: PENN Shoulder Score 1. The PENN Shoulder Score is used to assess patient self-reported levels of pain, satisfaction and function. 2. PENN is measured on a 0 - 100 point scale; higher scores indicate better outcomes. 3. The PENN consists of 3 subscales: pain (at rest, with activity, and with strenuous activity), satisfaction and function. The PENN Pain subscale is scored from 0 to 30, the PENN satisfaction subscale is scored from 0 to 10 and the PENN function subscale is scored from 0 to 60.
SANE
Time frame: two year post op
4. SANE: Single assessment numeric evaluation 1. SANE is an outcome scale used to record the patient's self-reported function. 2. SANE is implemented on a scale of 0 - 100, 100 indicates full function (or function prior to injury) and 0 represents no function.
CS
Time frame: two year post op
5. CS: Constant-Murley Score 1. The CS score assesses functionality after the treatment of a shoulder injury. 2. CS is measured on a 0 - 100 point scale. Higher scores indicate better shoulder function. 3. CS is composed of four subscales: pain (15 points, based on patient report), activities of daily living (20 points, based on patient report), strength (25 points), and range of motion (40 points).
WOOS
Time frame: two year post op
6. WOOS: Western Ontario Osteoarthritis of the Shoulder index 1. WOOS is a disease-specific quality of life PRO tool, developed for osteoarthritis. 2. WOOS is measured on a 0-1900 point scale; 1900 indicates a clinical outcome fully symptomatic of osteoarthritis and 0 indicates an asymptomatic outcome. i. WOOS is composed of 19 items scored on 100-point VAS scales. The 19 items represent four domains (6 questions for pain and physical symptoms, 5 questions for sport/recreation/work function, 5 questions for lifestyle function and 3 questions for emotional function).
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 20 May 2019.
- Individual participant dataSharing planned: No. Data will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Disease, run by OrthoIndy.
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 1 inclusion and 1 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 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
ASES (time frame: two year post op). The study lists 6 primary outcomes in all. 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 20 May 2019.