At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Nexel Total Elbow (device)
- How long the study runs
- Study runs about 258 months (dates as stated)
- About the drug or intervention
- Nexel Total Elbow — device: Nexel Total Elbow used in primary or revision total elbow arthroplasty
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at how well the Nexel Total Elbow replacement works for people with serious elbow problems. These problems include badly damaged elbow joints, arthritis, stiff or fused joints, fractures, and instability. Zimmer Biomet, the company that makes the device, is running the study.
Who can take part
- Adults aged 18 or over
- People due to have a first or repeat full elbow replacement
- Elbow problems such as joint damage affecting daily life, injury-related damage or bone loss, fused or stiff joints (especially both elbows), severe rheumatoid arthritis, injury-related or wear-and-tear arthritis with severe pain, instability or loss of movement, or a serious shattered fracture of the elbow joint surfaces
- Able and willing to agree (give informed consent) and attend the study follow-up checks set out in the plan
- For the retrospective (look-back) part: people who already had a Nexel elbow replacement since July 2013, with their past medical records available
Who may not be able to
- Active or repeated infection at the elbow, or a major infection elsewhere in the body
- Previous blood poisoning (sepsis)
- Paralysis or nerve problems affecting the elbow, or poor use of the hand on the same side
- Heavy scarring near the elbow that could stop proper healing
- Daily activities that could stress the new joint a lot, such as heavy labour, twisting movements, or competitive sport
- Being in prison
- Being unable to understand what taking part means
- Known alcohol or drug misuse, or being unlikely to follow the study plan
- Known pregnancy
What taking part involves
- • Surgery to replace the elbow joint with the Nexel Total Elbow device
- • Attending follow-up checks as set out in the study plan — exact tests and timings: Not stated — ask the trial team
Time commitment: You would have elbow replacement surgery and attend scheduled follow-up checks; how many visits and how long the study lasts are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 134
- Started
- 2015-06
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for elbow joint destruction
- • NA - 134 participants
- • The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with elbow joint destruction
Where?
- • Wigan - Wrightington
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.
More detail
The objectives of the study are to confirm safety and performance of the Zimmer® Nexel™ Total Elbow when used in primary or revision total elbow replacement by analysis of standard scoring systems, radiographs, and adverse event records. The safety of the device will be monitored using the frequency and incidence of reporting adverse events. The performance of the device will be evaluated by assessing the pain and functional performance, survival of the device, patient health status, and radiographic success of the implant.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent
What the study is looking for
- ✓Patient is 18 years of age or older.
- ✓Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved agreement to take part.
- ✓Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of...
- ✓Elbow joint destruction which significantly compromises daily living activities
- ✓Post-traumatic lesions or bone loss contributing to elbow instability
Who cannot take part
- ✗Patient has a currently active or history of repeated local infection at the surgical site.
- ✗Patient has a current major infection distant from the operative site.
- ✗Patient has a history of prior sepsis.
- ✗Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.
- ✗Patient has significant ipsilateral hand dysfunction.
See the full criteria
Where Is This Study? (1 UK site)
Wrightington
Wigan, United Kingdom
How to Get in Touch
Richard Marek
Sponsor contactCONTACT
Ryan Boylan
Sponsor contactCONTACT
