Arthroplasty ComplicationsNCT06615739
Comprehensive SRS Regenerex Tissue Attachment
An observational study of Arthroplasty Complications and Osteo Arthritis Shoulders, run by Zimmer Biomet at 1 site in United States.
Trial summary
The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb salvage arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty Complications, Osteo Arthritis Shoulders
- What is being tested?
- Regenerex Tissue Attachment Augments
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2024to 26 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects must meet the inclusion criteria to be enrolled into the study. Subjects who meet any of the exclusion criteria should not be enrolled into the study. The study population will comprise a consecutive cohort of up to 103 subjects implanted using the Comprehensive SRS Regenerex Tissue Attachment Augments.
Who may be able to join
- Patient must be 18 years of age or older.
- Patient must be willing and able to follow directions.
- The Comprehensive Segmental Revision System was used in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
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- Oncology applications including bone loss due to tumor resection.
- Proximal or total humeral replacement, for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
- Distal or total humeral replacement for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
- Biomet Comprehensive Segmental Revision System was used in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff for proximal humeral replacement. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- The Comprehensive Segmental Revision System was used with bone cement in distal humeral and total humeral applications.
- Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision System
Who cannot join
- Absolute contraindications:
- Infection
- Sepsis
- Osteomyelitis
- Patient is a prisoner
- Patient is a current alcohol or drug abuser
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- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
- Patient is unwilling to consent
- Relative contraindications:
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Vascular insufficiency, muscular atrophy, or neuromuscular disease
- The Comprehensive Segmental Revision System was used in a reverse shoulder application in patients receiving radiation therapy
- The Comprehensive Segmental Revision System was used without bone cement in distal humeral and total humeral applications.
- Regenerex Tissue Attachment Augments weren't used during the patient's surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Toman Orthopedics and Sports Med
Boca Raton, Florida, 33432
About this study
Official title: PMCF Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Segmental Revision System (SRS) Regenerex Tissue Attachment Augments - A Retrospective Enrollment and Prospective Follow-up Consecutive Series Study
The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb salvage arthroplasty.
Read the detailed description
Consecutive subjects implanted with Comprehensive SRS Regenerex Tissue Attachment Augments according to the approved indications, with the longest-term follow-up possible, will be identified and invited to participate in the study.
The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to the implant and/or procedure should be specified.
The study will include one site. There will be a maximum of 103 patients enrolled in the study.
- Being tested
- Regenerex Tissue Attachment Augments
- Keywords
- Medical Device, Safety, Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerex Tissue Attachment AugmentsDevice
Patient will have been previously implanted with Regenerex Tissue Attachment Augments in combination with the Comprehensive Segmental Revision System
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Regenerex Tissue Attachment Augments | Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision system Receives: Device: Regenerex Tissue Attachment Augments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan Meier Implant Survivorship
This will be established by recording the incidence and frequency of device revisions. Kaplan-Meier survival analysis is a statistical method that estimates survival rates over time and accounts for factors that can affect implant survival.
Measured: Up to 10 Years
Safety Assessement
This will be established by recording the incidence and frequency of complications and adverse events. Relation of the events to the implant and/or procedure will be specified.
Measured: Up to 10 Years
Secondary outcomes (1)
Assessment of performance and clinical benefits by recording patient reported QuickDASH
QuickDASH, or Quick Disabilities of the Arm, Shoulder, and Hand, is a questionnaire that measures the impact of upper limb musculoskeletal disorders on physical function and symptoms.
The QuickDASH has 11 items that cover six domains:
Daily activities: How much difficulty the patient has performing physical activities Symptoms: How severe the patient's pain and tingling is Social function: How the patient's problem affects their social activities Work function: How the patient's problem affects their work Sleep: How the patient's problem affects their sleep Confidence: How the patient's problem affects their confidence
Each item is rated on a 5-point Likert scale, with 1 being no difficulty and 5 being unable. The score is then converted to a 100-point scale, with 100 representing the greatest disability.
Measured: Up to 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start22 Oct 2024
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Osborn, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615739
- Sponsor's protocol ID
- CMU2024-12E
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: IPD may not be shared due to this being a single center retrospective enrollment/prospective FUP with one single reference point. Additionally, data is being collected for EU regulatory purposes.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMCF Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Segmental Revision System (SRS) Regenerex Tissue Attachment Augments - A Retrospective Enrollment and Prospective Follow-up Consecutive Series Study
- ClinicalTrials.gov ID
- NCT06615739
- Acronym / sponsor ID
- CMU2024-12E
- Keywords
- Medical Device, Safety, Performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 27 Sep 2024 (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 objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb salvage arthroplasty.
Detailed description
Consecutive subjects implanted with Comprehensive SRS Regenerex Tissue Attachment Augments according to the approved indications, with the longest-term follow-up possible, will be identified and invited to participate in the study.
The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to the implant and/or procedure should be specified.
The study will include one site. There will be a maximum of 103 patients enrolled in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Regenerex Tissue Attachment Augments | – | Device: Regenerex Tissue Attachment AugmentsRegenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must meet the inclusion criteria to be enrolled into the study. Subjects who meet any of the exclusion criteria should not be enrolled into the study. The study population will comprise a consecutive cohort of up to 103 subjects implanted using the Comprehensive SRS Regenerex Tissue Attachment Augments.
Key inclusion criteria (12 listed)
- Patient must be 18 years of age or older.
- Patient must be willing and able to follow directions.
- The Comprehensive Segmental Revision System was used in cases of:
- Proximal or total humeral replacement, for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
- Distal or total humeral replacement for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
Key exclusion criteria (18 listed)
- Absolute contraindications:
- Relative contraindications:
- The Comprehensive Segmental Revision System was used in a reverse shoulder application in patients receiving radiation therapy
- The Comprehensive Segmental Revision System was used without bone cement in distal humeral and total humeral applications.
- Regenerex Tissue Attachment Augments weren't used during the patient's surgery
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 |
|---|---|---|
| Regenerex Tissue Attachment AugmentsPatient will have been previously implanted with Regenerex Tissue Attachment Augments in combination with the Comprehensive Segmental Revision System | Device | Comprehensive Regenerex Tissue Attachment Augments |
Primary outcome
Kaplan Meier Implant Survivorship
Time frame: Up to 10 Years
This will be established by recording the incidence and frequency of device revisions. Kaplan-Meier survival analysis is a statistical method that estimates survival rates over time and accounts for factors that can affect implant survival.
Safety Assessement
Time frame: Up to 10 Years
This will be established by recording the incidence and frequency of complications and adverse events. Relation of the events to the implant and/or procedure will be specified.
1 secondary outcome
Assessment of performance and clinical benefits by recording patient reported QuickDASH
Time frame: Up to 10 Years
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 5 Oct 2026.
- Individual participant dataSharing planned: Undecided. IPD may not be shared due to this being a single center retrospective enrollment/prospective FUP with one single reference point. Additionally, data is being collected for EU regulatory purposes.
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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.
Erin Osborn study director
Zimmer Biomet
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 Arthroplasty Complications and Osteo Arthritis Shoulders, run by Zimmer Biomet 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 12 inclusion and 18 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 5 Oct 2026. 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?
Kaplan Meier Implant Survivorship (time frame: Up to 10 Years). The study lists 2 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 5 Oct 2026.