Active not recruitingOBSERVATIONAL

Comprehensive Segmental Revision System

This study is gathering information on a new and complete system for replacing parts of the shoulder or elbow joint. It's designed for people who have severe joint problems due to conditions like arthritis, serious injuries, or if they've had surgery to remove a tumour. The study aims to see how well these implants perform in real patients over time. Doctors will collect information on how patients recover and how their arm or shoulder feels and functions after the operation. This data will help medical engineers improve the implants, guide future marketing, answer questions from health funding bodies, and is part of ongoing safety monitoring. Participants will be followed for at least 10 years to get a full picture of the treatment's success.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

105

Start

01 Apr 2016

Estimated completion

01 Dec 2035

Degenerative Disease Oncology Revision Surgery Trauma Rheumatoid Arthritis

What is this study about?

This study is about a special type of surgery that replaces parts of the shoulder or elbow. It's called the "Comprehensive Segmental Revision System." Think of it as a complete kit for fixing problems in these joints. This system can replace just the shoulder joint, just the elbow joint, or the whole arm bone connecting the shoulder and elbow if needed.

This kind of surgery is typically considered for people with serious joint issues. This includes conditions where the joint wears out over time (like osteoarthritis), painful arthritis (like rheumatoid arthritis), or if someone has had a previous operation that didn't work well. It's also used for severe injuries or if bone needs to be removed because of a tumour.

The main goal of this study is to carefully watch and record how well these new implants work in people over many years. Doctors will use special questionnaires and scoring systems to see how patients' pain improves, and how well they can move and use their arm and shoulder. This information is really important because it helps the people who design these implants make them even better, and it ensures that healthcare providers understand their effectiveness.

Key takeaways

It's a study on a shoulder/elbow replacement system for severe joint problems.
It helps doctors understand how well the implants work long-term.
Patients are followed for at least 10 years after surgery.
It's for conditions like arthritis, injuries, or after tumour surgery.
You can't join if you have an active infection.

Who may be eligible?

You might be able to take part in this study if you need surgery for certain problems in your shoulder or elbow. This includes conditions where your joint has worn out, like osteoarthritis, or if you have rheumatoid arthritis. It also applies if you've had a previous joint replacement or treatment that didn't work, for serious injuries, or if you need bone removed due to a tumour.

However, you won't be able to join the study if you currently have an active infection, such as sepsis (a severe body-wide infection), any other active infection in your body, or a bone infection called osteomyelitis. These conditions could make the surgery too risky or affect how well the new joint replacement works.

Anyone, regardless of age or gender, who meets these general health and medical requirements might be suitable for the study.

Quick self-check

Do I have a serious problem with my shoulder or elbow joint?
Has my joint worn out, do I have rheumatoid arthritis, or a bad injury?
Might I need surgery because a previous joint treatment didn't work?
Do I need bone removed due to a tumour?
Do I currently have an active infection (like sepsis or a bone infection)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the Comprehensive Segmental Revision System as part of your surgery. After your operation, doctors will regularly monitor your recovery and the function of your new joint. This will involve filling out questionnaires about your pain and how well you can use your arm. One common questionnaire is called the quickDASH, which measures your arm, shoulder, and hand disability. Depending on your specific case, other scores might also be used to assess your shoulder or elbow.

There won't be any specific extra medications required for the study itself, beyond what's needed for your surgery and recovery. The most significant part of your involvement is the long-term follow-up. The study will track your progress and the performance of your implant for at least 10 years from the date of your surgery. This means occasional check-ups and assessments over this period.

Potential risks and benefits

Taking part in this study means you would receive an advanced joint replacement system designed to address challenging bone and joint problems. Potential benefits could include improved pain relief, better movement, and greater ability to use your arm and shoulder. As with any surgery, there are risks, such as infection, problems with healing, or the possibility of the implant needing further attention in the future. The study aims to gather long-term data on the safety and effectiveness of this specific system. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (4)

Nova Scotia Health Authority
Halifax, Canada
Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen
Copenhagen, Denmark
Royal Gwent Hospital
Newport, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom

Common questions

What kind of problems does this joint replacement system fix?

It fixes severe problems in the shoulder or elbow caused by arthritis, serious injuries, previous failed surgeries, or bone loss due to tumours.

How long will I be followed in this study?

You will be followed for at least 10 years after your surgery to see how well the implant works over time.

Will I have extra doctor's visits if I join?

You will have regular follow-up visits and fill out questionnaires to check your progress, but these will be part of your normal post-operative care for such a surgery.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, and it will not affect your medical care.

Is this a new type of operation?

The study is looking at a specific comprehensive system for joint replacement, evaluating its performance and outcomes in patients.