Total Elbow ArthroplastyNCT05180071
A Post-market Study Evaluating Clinical and Radiographic Outcomes of Total Elbow Arthroplasty With TEMA
A study testing TEMA elbow system in people with Total Elbow Arthroplasty, run by Limacorporate S.p.a.
Trial summary
TEMA elbow system is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Elbow Arthroplasty
- What is being tested?
- TEMA elbow system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 30 Jun 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's age ≥ 18 years old.
- Patient has given written informed consent to participate to the trial and to his/her personal data processing
- According to the device indications for use, patient suffers from disability due to one or more of the following:
- Elbow joint destruction which significantly compromises the activities of daily living
- Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis with hemophilia.
- Rheumatoid arthritis or degenerative arthritis with incapacitating pain
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- Correction of severe functional deformity.
- Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
- Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion
- Any other medical reason that the investigator determine that subject is a good candidate for a total elbow arthroplasty
- Patient has undergone a total elbow arthroplasty, receiving TEMA prosthesis.
- Patient is able to comply with the study protocol.
Who cannot join
- A patient will be excluded from the study participation if he/she meets any of the following criteria:
- Patient is affected by one or more of the conditions that are stated as TEMA contraindications for use, which are:
- Local or systemic infection;
- Septicemia;
- Persistent acute or chronic osteomyelitis.
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions;
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- Osteoporosis;
- Metabolic disorders which may impair bone formation;
- Rapid joint destruction, marked bone loss or bone resorption.
- Patient suffers from a diaphyseal fracture
- For female patients, current pregnancy and/or lactation or planning a pregnancy.
- Only for patients implanted with the unlinked configuration of TEMA prosthesis, the intraoperative testing showed a bad quality of medial and lateral elbow ligaments.
- Patient is enrolled in another investigational drug/device study that in the opinion of the Investigator could interfere with this clinical trial
About this study
TEMA elbow system is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within five years after the surgery, and thus to assess the short-term performance and safety of this implant.
- Conditions
- Total Elbow Arthroplasty
- Being tested
- TEMA elbow system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEMA elbow systemDevice
Total elbow replacement
| Study group | Role | What they receive |
|---|---|---|
| TEMA elbow arthroplasty | Experimental | Not described Receives: Device: TEMA elbow system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Elbow Score improvement at three ears FU
Functional change in Oxford Elbow Score (OES) from preoperative (baseline) to 2 years of follow-up.
Measured: 2 years Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Feb 2024 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Elbow ArthroplastyStudies of the same condition, open and under way.
- More trials run by Limacorporate S.p.aThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180071
- Sponsor's protocol ID
- E-02
- Status last verified
- Sep 2023
- First submitted
- 17 Dec 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Study Evaluating Clinical and Radiographic Outcomes of Total Elbow Arthroplasty With TEMA
- ClinicalTrials.gov ID
- NCT05180071
- Acronym / sponsor ID
- E-02
- Conditions
- Total Elbow Arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 6 Jan 2022 (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.
TEMA elbow system is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within five years after the surgery, and thus to assess the short-term performance and safety of this implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEMA elbow arthroplasty | Experimental | Device: TEMA elbow system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient's age ≥ 18 years old.
- Patient has given written informed consent to participate to the trial and to his/her personal data processing
- According to the device indications for use, patient suffers from disability due to one or more of the following:
- Patient has undergone a total elbow arthroplasty, receiving TEMA prosthesis.
- Patient is able to comply with the study protocol.
Key exclusion criteria (13 listed)
- A patient will be excluded from the study participation if he/she meets any of the following criteria:
- Patient is affected by one or more of the conditions that are stated as TEMA contraindications for use, which are:
- Patient suffers from a diaphyseal fracture
- For female patients, current pregnancy and/or lactation or planning a pregnancy.
- Only for patients implanted with the unlinked configuration of TEMA prosthesis, the intraoperative testing showed a bad quality of medial and lateral elbow ligaments.
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 |
|---|---|---|
| TEMA elbow systemTotal elbow replacement | Device | TEMA elbow arthroplasty |
Primary outcome
Oxford Elbow Score improvement at three ears FU
Time frame: 2 years Follow up
Functional change in Oxford Elbow Score (OES) from preoperative (baseline) to 2 years of follow-up.
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 12 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TEMA elbow system in people with Total Elbow Arthroplasty, run by Limacorporate S.p.a.
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 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: opening soon, as of the sponsor's last update on 12 Dec 2023. 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?
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?
Oxford Elbow Score improvement at three ears FU (time frame: 2 years Follow up). 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 12 Dec 2023.