AuthorisedTherapeutic exploratory (Phase II)Interventional

Influence Of Zoledronic Acid On Healing After Arthroskopic Repair Of Chronic Rotator Cuff Lesions A Prospective, Randomized, Placebo-Controlled Phase II Trial ZORRO

The ZORRO study is a research project investigating how zoledronic acid might help people recover after surgery to repair a torn shoulder tendon. These tendony tears can happen after an injury. The study is particularly interested in whether this medicine, which is sometimes used for people with weak bones (osteoporosis), can stop the tear from coming back after keyhole surgery. Researchers will be comparing people who receive zoledronic acid with those who receive a dummy treatment (placebo) to see if there's a difference in how well their tendons heal and how their shoulder functions over several years. This type of study, called a Phase II trial, helps us understand if a new treatment has potential before it's studied in larger groups.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

AUVA Trauma Center Vienna

Enrolment target

Start

14 Jan 2025

Trauma (rupture of a tendon)Osteoporosis

What is this study about?

This research study, known as ZORRO, is looking into how a specific medicine might improve healing for people who have had shoulder surgery. Sometimes, after an injury, tendons in your shoulder can tear. Doctors can fix these tears with an operation, often using a small camera (arthroscopy) to minimise the cut. However, sometimes these tears can happen again, which doctors call a 're-rupture.' This study wants to find out if giving a medicine called zoledronic acid can help prevent the tendon from tearing again after surgery.

Zoledronic acid is a medicine that is already used for certain bone conditions, like osteoporosis, which makes bones weak. Researchers are interested in whether this medicine could also help tendons heal better by affecting the way the body repairs itself. By giving zoledronic acid to some patients and a dummy treatment (placebo) to others, the study aims to see if the medicine really makes a difference to how strong the shoulder tendon becomes after surgery and how well people can use their arm.

They will be carefully checking how the tendon heals at different times after the operation – 6 months, 1 year, 2 years, and even 5 years later. They'll also measure how much pain people have, how strong their shoulder is, and how easily they can move their arm. This information will help doctors understand if zoledronic acid could be a helpful new treatment to improve long-term results for people having surgery for shoulder tendon tears, especially if they also have conditions like weak bones.

Key takeaways

Study looks at how a medicine might help shoulder tendons heal after surgery.
Aims to prevent the tendon from re-tearing after keyhole surgery.
Compares zoledronic acid to a dummy treatment.
Involves regular check-ups and assessments for up to 5 years.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Generally, participants will be people who have had a recent shoulder injury resulting in a torn tendon, and who are having keyhole surgery to fix that tear. This study is also interested in people who might have conditions that affect their bones or how their body heals.

There might be other specific health requirements or conditions that would mean you can or cannot take part, so it’s always best to discuss it fully with the study doctor.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently had a torn shoulder tendon that needs surgery?
Are you having 'keyhole' surgery (arthroscopy) for your shoulder?
Are you able to attend follow-up appointments for up to 5 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance to receive either the study medicine, zoledronic acid, or a dummy treatment (placebo). Neither you nor your doctor will know which treatment you are receiving until after the study is over.

You will have check-ups at different times after your shoulder surgery, including at 6 months, 1 year, 2 years, and 5 years. These appointments will involve various assessments, such as checking your shoulder's strength, how well it moves, and how much pain you might have. Doctors will also use special scans to see how your tendon is healing. Your participation will last for a total of five years to fully understand the long-term effects of the treatment.

Potential risks and benefits

Taking part in this study might offer a potential benefit if zoledronic acid helps your tendon heal better and stops re-tearing, but this is not guaranteed as it's a research study. There could also be side effects from zoledronic acid, and these will be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What is a 'rotator cuff tear'?

It's an injury to a group of tendons and muscles around your shoulder joint, often causing pain and weakness.

What is zoledronic acid?

It's a medicine often used to strengthen bones, but in this study, we're exploring if it helps tendon healing.

What does 'placebo-controlled' mean?

Some people get the medicine, and others get a dummy treatment that looks the same but has no active ingredient. This helps us see if the medicine really works.

How long will I be in the study?

Your participation will involve follow-up appointments for up to 5 years after your surgery.

Will I know if I'm getting the real medicine?

No, it's a 'blinded' study, meaning neither you nor your doctor will know if you're getting the medicine or the placebo until the study ends.