Severe Arthropathy With a Grossly Deficient Rotator CuffNCT03711175
The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty
A study testing Subscapularis repair and Shoulder implant in people with Severe Arthropathy With a Grossly Deficient Rotator Cuff, run by Encore Medical, L.P. at 4 sites in United States.
Trial summary
The study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Severe Arthropathy With a Grossly Deficient Rotator Cuff
- What is being tested?
- Subscapularis repair and Shoulder implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Sep 2018to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥21 years of age
- Subject is scheduled for reverse shoulder arthroplasty with the AltiVate Reverse device due to primary diagnosis of severe arthropathy with a grossly deficient rotator cuff
- Subject's sub scapularis has been determined from MRI to be sufficient to repair
- Subject is willing and able to comply with the study schedule and assessments
- Subject is likely to be available for evaluation for the duration of the study
- Subject is willing and able to sign the informed consent
Who cannot join
- Subject is indicated for reverse shoulder arthroplasty for other indications (revision arthroplasty, proximal humerus fracture, etc.), addition of latissimus transfer or pectoralis major transfer
- Subject has metal allergies or sensitivity
- Subject has an active infection at or near the site of implantation
- Subject has a nonfunctional deltoid muscle
- Subject has neuromuscular compromise condition of the shoulder
- Subject has known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
Show all 13Show fewer
- Subject is currently on or planning to be on chemotherapy or radiation
- Subject has had chemotherapy or radiation within the last 6 months
- Subject is currently taking > 5mg/day corticosteroids (e.g. prednisone), excluding inhalers, within 3 months prior to surgery
- Female subjects who are pregnant or planning to become pregnant within the study period
- In the investigator's opinion, the subject is unable to understand the study or be compliant with the follow up or has a history of non-compliance with medical advice
- Subject has a history of any cognitive or mental health status that would interfere with study participation
- Subject is abusing alcohol or drugs or is undergoing active treatment for substance abuse (e.g., recreational drugs, narcotics, or alcohol).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Texas Orthopedic Group
Houston, Texas, 77030
NYU Langone Center for Musculoskeletal Care
New York, New York, 10016
Rothman Institute
Philadelphia, Pennsylvania, 19107
St. Luke's Hospital
St Louis, Missouri, 63128
About this study
Official title: A Prospective Multicenter Study to Examine the Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty: A Randomized, Controlled Trial.
The study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational strength. It is hypothesized that patients in which the subscapularis is repaired will have improved postoperative isometric and isokinetic internal rotational strength.
Read the detailed description
Reverse shoulder arthroplasty (RSA) is performed to provide improvement in pain relief and restoration of function in patients with rotator cuff tear arthropathy and massive irreparable rotator cuff tears . Traditional total shoulder designs failed to address the unique mechanics of shoulders with deficient rotator cuffs. Different prosthesis designs exist for RSA, all of which increase the deltoid lever arm to provide a stable fulcrum for active elevation in a rotator cuff deficient shoulder.
The Reverse® Shoulder Prosthesis (RSP®) (DJO Surgical) sought to address issues correlated to the Grammont design by lateralizing the center of rotation as well as utilizing a central compressive screw with a 5.0-mm peripheral locking screws for fixation and a glenosphere .
Despite the success of the lateralized design, the effect of the repair of the subscapularis tendon during RSA on shoulder strength, range of motion, and shoulder function remains inconclusive. The rationale for repairing the subscapularis during RSA include anatomic preservation of a functioning rotator cuff muscle, an increased potential for internal rotation, better joint protection, and more stability. The reasoning for not repairing the subscapularis include that it may be biomechanically unfavorable for both the deltoid and the posterior rotator cuff, limiting the range of motion.
As such, this randomized study aims to address if subscapularis repair impacts isometric and isokinetic internal rotational strength, with shoulder function and complications as secondary objectives, when patients are implanted with the AltiVate Reverse® device.
The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department.
- Being tested
- Subscapularis repair, Shoulder implant
- Keywords
- Sub-scapularis repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subscapularis repairProcedure or surgery
Utilizing fiberwire, high tensile strength suture
Shoulder implantDevice
Reverse shoulder arthroplasty device
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | The subscapularis is repaired. Receives device Receives: Procedure: Subscapularis repair; Device: Shoulder implant |
| Group B | Other | The subscapularis is not repaired. Receives device Receives: Device: Shoulder implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in isometric and isokinetic internal rotational strength of abductors
Maximal isometric strength of shoulder abductors and measured in kilograms using a force gauge
Measured: 6 months, and 1, 2, 5 and 10 years
Change in isometric and isokinetic internal rotational strength of flexors
Maximal isometric strength of shoulder flexors measured in kilograms using a force gauge
Measured: 6 months, and 1, 2, 5 and 10 years
Change in isometric and isokinetic internal rotational strength of internal rotators
Maximal isometric strength of shoulder measured internal rotators in kilograms using a force gauge
Measured: 6 months, and 1, 2, 5 and 10 years
Change in isometric and isokinetic internal rotational strength of external rotators
Maximal isometric strength of shoulder measured external rotators in kilograms using a force gauge
Measured: 6 months, and 1, 2, 5 and 10 years
Secondary outcomes (10)
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Examine operative shoulder active forward elevation
Measured: 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Examine operative shoulder active abduction
Measured: 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Examine operative shoulder active external rotation
Measured: 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Examine operative shoulder active internal rotation
Measured: 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Examine change in ASES score
Measured: 6 weeks,6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Examine change in pain per ASES assessment
Measured: 6 weeks, 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Examine change in SST score
Measured: 6 weeks,6 months, and 1, 2, 5 and 10 years
To evaluate change in general health with the AltiVate Reverse® Shoulder
Examine change in VR-12
Measured: 6 weeks, 6 months, and 1, 2, 5 and 10 years
To evaluate change in the radiographs of AltiVate Reverse® Shoulder
Examine radiographic parameters
Measured: 6 weeks, 6 months, and 1, 2, 5 and 10 years
To evaluate device survivorship of the AltiVate Reverse® Shoulder
Examine adverse events
Measured: 6 weeks, 6 months, and 1, 2, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start28 Sep 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Arthropathy With a Grossly Deficient Rotator CuffStudies 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
- Model description
- Two treatment arms. One group will have the subscapularis repaired during surgery, and one group will not have the subscapularis repaired during surgery. All subjects will receive the same device.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Knowlton, MS, CRA, Study director, DJO Global
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711175
- Sponsor's protocol ID
- PS-903
- Status last verified
- Mar 2022
- First submitted
- 11 Oct 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study to Examine the Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty: A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT03711175
- Acronym / sponsor ID
- PS-903
- Keywords
- Sub-scapularis repair
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Oct 2018 (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 study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational strength. It is hypothesized that patients in which the subscapularis is repaired will have improved postoperative isometric and isokinetic internal rotational strength.
Detailed description
Reverse shoulder arthroplasty (RSA) is performed to provide improvement in pain relief and restoration of function in patients with rotator cuff tear arthropathy and massive irreparable rotator cuff tears . Traditional total shoulder designs failed to address the unique mechanics of shoulders with deficient rotator cuffs. Different prosthesis designs exist for RSA, all of which increase the deltoid lever arm to provide a stable fulcrum for active elevation in a rotator cuff deficient shoulder.
The Reverse® Shoulder Prosthesis (RSP®) (DJO Surgical) sought to address issues correlated to the Grammont design by lateralizing the center of rotation as well as utilizing a central compressive screw with a 5.0-mm peripheral locking screws for fixation and a glenosphere .
Despite the success of the lateralized design, the effect of the repair of the subscapularis tendon during RSA on shoulder strength, range of motion, and shoulder function remains inconclusive. The rationale for repairing the subscapularis during RSA include anatomic preservation of a functioning rotator cuff muscle, an increased potential for internal rotation, better joint protection, and more stability. The reasoning for not repairing the subscapularis include that it may be biomechanically unfavorable for both the deltoid and the posterior rotator cuff, limiting the range of motion.
As such, this randomized study aims to address if subscapularis repair impacts isometric and isokinetic internal rotational strength, with shoulder function and complications as secondary objectives, when patients are implanted with the AltiVate Reverse® device.
The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two treatment arms. One group will have the subscapularis repaired during surgery, and one group will not have the subscapularis repaired during surgery. All subjects will receive the same device.
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Procedure: Subscapularis repair, Device: Shoulder implantThe subscapularis is repaired. Receives device |
| Group B | Other | Device: Shoulder implantThe subscapularis is not repaired. Receives device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is ≥21 years of age
- Subject is scheduled for reverse shoulder arthroplasty with the AltiVate Reverse device due to primary diagnosis of severe arthropathy with a grossly deficient rotator cuff
- Subject's sub scapularis has been determined from MRI to be sufficient to repair
- Subject is willing and able to comply with the study schedule and assessments
- Subject is likely to be available for evaluation for the duration of the study
Key exclusion criteria (13 listed)
- Subject is indicated for reverse shoulder arthroplasty for other indications (revision arthroplasty, proximal humerus fracture, etc.), addition of latissimus transfer or pectoralis major transfer
- Subject has metal allergies or sensitivity
- Subject has an active infection at or near the site of implantation
- Subject has a nonfunctional deltoid muscle
- Subject has neuromuscular compromise condition of the shoulder
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 |
|---|---|---|
| Subscapularis repairUtilizing fiberwire, high tensile strength suture | Procedure or surgery | Group A |
| Shoulder implantReverse shoulder arthroplasty device | Device | Group A, Group B |
Primary outcome
Change in isometric and isokinetic internal rotational strength of abductors
Time frame: 6 months, and 1, 2, 5 and 10 years
Maximal isometric strength of shoulder abductors and measured in kilograms using a force gauge
Change in isometric and isokinetic internal rotational strength of flexors
Time frame: 6 months, and 1, 2, 5 and 10 years
Maximal isometric strength of shoulder flexors measured in kilograms using a force gauge
Change in isometric and isokinetic internal rotational strength of internal rotators
Time frame: 6 months, and 1, 2, 5 and 10 years
Maximal isometric strength of shoulder measured internal rotators in kilograms using a force gauge
Change in isometric and isokinetic internal rotational strength of external rotators
Time frame: 6 months, and 1, 2, 5 and 10 years
Maximal isometric strength of shoulder measured external rotators in kilograms using a force gauge
10 secondary outcomes
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Time frame: 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Time frame: 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Time frame: 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder ROM with the AltiVate Reverse® Shoulder
Time frame: 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Time frame: 6 weeks,6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Time frame: 6 weeks, 6 months, and 1, 2, 5 and 10 years
To evaluate change in shoulder functionality with the AltiVate Reverse® Shoulder
Time frame: 6 weeks,6 months, and 1, 2, 5 and 10 years
To evaluate change in general health with the AltiVate Reverse® Shoulder
Time frame: 6 weeks, 6 months, and 1, 2, 5 and 10 years
To evaluate change in the radiographs of AltiVate Reverse® Shoulder
Time frame: 6 weeks, 6 months, and 1, 2, 5 and 10 years
To evaluate device survivorship of the AltiVate Reverse® Shoulder
Time frame: 6 weeks, 6 months, and 1, 2, 5 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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.
Jessica Knowlton, MS, CRA study director
DJO Global
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subscapularis repair and Shoulder implant in people with Severe Arthropathy With a Grossly Deficient Rotator Cuff, run by Encore Medical, L.P. at 4 sites 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 6 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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 in isometric and isokinetic internal rotational strength of abductors (time frame: 6 months, and 1, 2, 5 and 10 years). The study lists 4 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 22 Mar 2022.