Degenerative DiseaseNCT03270982
Comprehensive Segmental Revision System
An observational study of Degenerative Disease and Oncology, run by Zimmer Biomet at 4 sites in 3 countries.
Trial summary
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disease, Oncology, Revision Surgery
- What is being tested?
- Comprehensive SRS Replacement
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Apr 2016to Dec 2035
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will come from Primary Care Clinics
Who may be able to join
- Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular necrosis
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Oncology applications including bone loss due to tumour resection
Who cannot join
- Sepsis ( active)
- Infection ( active)
- Osteomyelitis (active)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Royal Liverpool University Hospital
Liverpool
Royal Gwent Hospital
Newport, Wales, NP20 2UB
Denmark1 site
Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen
Copenhagen
About this study
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.
Read the detailed description
The Purpose of this multi centre clinical data evaluation is to document the performance and clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as part of Zimmer Biomets Post Market Surveillance.
The Comprehensive Segmental Revision System consists of a proximal humeral replacement system (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler).
Patient outcomes will be measured by using measurement tools that have been extensively used and referred to in the literature. Specifically, the quickDASH will be used for all cases enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score may be used for tumor cases.
The study population will be compromised of males and females that are eligible according to the inclusion/exclusion criteria. The study will last for at least ten (10) years from the time of surgery.
- Conditions
- Degenerative Disease, Oncology, Revision Surgery, Trauma, Rheumatoid Arthritis
- Being tested
- Comprehensive SRS Replacement
- Keywords
- Non Inflammatory Degenerative Joint Disease, Rheumatoid Arthritis, Revision where other devices have failed, Correction of functional deformity, Oncology Applications, Treatment of acute or Chronic fractures
- Medical subject headings
- Neoplasms, Wounds and Injuries, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive SRS ReplacementDevice
This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive SRS Replacement | Comprehensive SRS Device Receives: Device: Comprehensive SRS Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survivorship assessed according to the implant revisions
Implant survivorship assessed counting the number of implant revisions
Measured: 10 years
Secondary outcomes (5)
Clinical patient outcome measure: QuickDASH
The QuickDASH score will be used to measure physical function and symptoms of the upper limb in patients to be treated/treated with the Comprehensive SRS products.
Measured: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
Clinical patient outcome measure: Constant-Murley Score
The Constant-Murley score may be used to define the level of pain and the ability to carry out the normal daily activities in patients to be treated/treated with the Comprehensive SRS products. The score consists of objective (ROM, strength) and subjective (pain, functional assessment) variables.
Measured: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
Clinical patient outcome measure: Liverpool Elbow Score
The Liverpool Elbow Score may be used to define elbow condition, function and pain in patients to be treated/treated with the Comprehensive SRS products.The score consists of two components: one patient-rated part and another part that can be measured objectively.
Measured: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS)
The MSTS Score may be used as a functional measure for patients with sarcoma involving the upper limb. The score includes 6 measures (pain, function, emotional acceptance, hand position, manual dexterity, lifting ability) each measure with a maximum of 5 points. The maximum overall score is 30 points. The score is designed to be used after the procedure and is therefore only collected post-operatively.
Measured: 6 months, 1 year, 3 years and 5 years post-operative
Safety is assessed according to the number of complications
Safety is assessed according to the number of complications which are collected via adverse event forms
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study startApr 2016
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative DiseaseStudies 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilie Rohmer, Study director, Clinical Operations Director Zimmer Biomet EMEA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270982
- Sponsor's protocol ID
- ORTHO.CR.GE5
- Status last verified
- Jun 2026
- First submitted
- 30 Aug 2017
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Segmental Revision System
- ClinicalTrials.gov ID
- NCT03270982
- Acronym / sponsor ID
- ORTHO.CR.GE5
- Conditions
- Degenerative Disease, Oncology, Revision Surgery, Trauma, Rheumatoid Arthritis
- Keywords
- Non Inflammatory Degenerative Joint Disease, Rheumatoid Arthritis, Revision where other devices have failed, Correction of functional deformity, Oncology Applications, Treatment of acute or Chronic fractures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 1 Sep 2017 (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.
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.
Detailed description
The Purpose of this multi centre clinical data evaluation is to document the performance and clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as part of Zimmer Biomets Post Market Surveillance.
The Comprehensive Segmental Revision System consists of a proximal humeral replacement system (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler).
Patient outcomes will be measured by using measurement tools that have been extensively used and referred to in the literature. Specifically, the quickDASH will be used for all cases enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score may be used for tumor cases.
The study population will be compromised of males and females that are eligible according to the inclusion/exclusion criteria. The study will last for at least ten (10) years from the time of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive SRS Replacement | – | Device: Comprehensive SRS ReplacementComprehensive SRS Device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will come from Primary Care Clinics
Key inclusion criteria (5 listed)
- Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular necrosis
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Oncology applications including bone loss due to tumour resection
Key exclusion criteria (3 listed)
- Sepsis ( active)
- Infection ( active)
- Osteomyelitis (active)
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 |
|---|---|---|
| Comprehensive SRS ReplacementThis system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement. | Device | Comprehensive SRS Replacement |
Primary outcome
Implant survivorship assessed according to the implant revisions
Time frame: 10 years
Implant survivorship assessed counting the number of implant revisions
5 secondary outcomes
Clinical patient outcome measure: QuickDASH
Time frame: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
Clinical patient outcome measure: Constant-Murley Score
Time frame: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
Clinical patient outcome measure: Liverpool Elbow Score
Time frame: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS)
Time frame: 6 months, 1 year, 3 years and 5 years post-operative
Safety is assessed according to the number of complications
Time frame: 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 9 Jun 2026.
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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.
Emilie Rohmer study director
Clinical Operations Director Zimmer Biomet EMEA
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disease and Oncology, run by Zimmer Biomet at 4 sites in 3 countries.
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: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. 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 Kingdom, Canada, Denmark. 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?
Implant survivorship assessed according to the implant revisions (time frame: 10 years). 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 9 Jun 2026.