Study on Zoledronic Acid for Healing After Rotator Cuff Surgery in Patients with Tendon Rupture and Osteoporosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Zoledronic Acid on the healing process after surgery for a shoulder condition known as a chronic rotator cuff tear. This condition involves a tear in the tendons around the shoulder joint, which can occur due to injury or wear and tear over time. The study also considers patients with osteoporosis, a condition where bones become weak and fragile. The purpose of the study is to see if Zoledronic Acid can help improve the healing of the tendon after it has been repaired through a procedure called arthroscopic surgery, which is a minimally invasive surgery using small incisions and a camera to guide the repair.

Participants in the study will receive either Zoledronic Acid or a placebo, which is a substance with no active medication, to compare the effects. The medication will be given through an infusion, which means it is delivered directly into the bloodstream via a vein. The study will monitor the healing of the tendon using magnetic resonance imaging (MRI), a type of scan that uses magnets and radio waves to create detailed images of the inside of the body. These scans will be done at several points over a period of up to five years after the surgery to assess the integrity of the tendon and see if it has healed properly without re-tearing.

In addition to the primary focus on tendon healing, the study will also look at other factors such as muscle condition, shoulder movement, strength, and pain levels. These will be evaluated using various scores and assessments to provide a comprehensive view of the shoulder’s recovery. The study aims to provide valuable insights into whether Zoledronic Acid can be a beneficial addition to the treatment plan for individuals undergoing surgery for chronic rotator cuff tears, particularly those who also have osteoporosis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 50 and 70 years, confirming a rotator cuff tear through magnetic resonance imaging (MRI) within the last 6 months, and ensuring the rupture size does not exceed 3 cm.

2 surgery and postoperative care

Participants undergo arthroscopic repair of the chronic rotator cuff lesion. Post-surgery, a shoulder abduction pad is used for four weeks as part of a unified physiotherapy program.

3 medication administration

Participants receive an intravenous infusion of zoledronic acid as part of the study. The specific dosage and frequency are determined by the study protocol.

4 follow-up assessments

Follow-up assessments are conducted at six, twelve, twenty-four, and sixty months post-surgery. These assessments include MRI scans to evaluate tendon integrity and check for any re-rupture.

Additional evaluations include measuring fatty muscle infiltration, shoulder movements such as abduction, adduction, anteversion, retroversion, internal and external rotation, shoulder strength, and pain levels. Scores such as the Constant-Murley-Score, American Shoulder and Elbow Surgeons Score, and Subjective Shoulder Value are also recorded.

Who Can Join the Study?

  • Age between 50 and 70 years
  • Confirmed rotator cuff tear through magnetic resonance imaging (MRI) within 6 months before surgery. MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
  • The tear in the tendon should not be larger than 3 cm in diameter
  • Willingness to participate in the study
  • Willingness to take part in a specific physiotherapy program, which includes using a shoulder abduction pad for four weeks after surgery. A shoulder abduction pad is a device that helps keep the shoulder in a certain position to aid healing.

Who Cannot Join the Study?

  • Patients with a history of trauma, which means a serious injury, specifically a rupture of a tendon, cannot participate.
  • Patients with osteoporosis, a condition where bones become weak and are more likely to break, are excluded.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Atcl Tokjol Celhyf Vjqkzn Vienna Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.09.2022

Trial locations

Investigated drugs:

Zoledronic Acid is a medication used in this clinical trial to see if it helps improve the healing of tendons after surgery. It is given through an intravenous infusion, which means it is delivered directly into the bloodstream. The study aims to find out if using zoledronic acid can make the tendons heal better after they have been repaired during surgery for chronic rotator cuff injuries. The researchers will use imaging techniques to check the condition of the tendons at different times after the surgery to see if the medication has a positive effect.

Investigated diseases:

Trauma (rupture of a tendon) – This condition occurs when a tendon, which connects muscle to bone, is torn or ruptured. It often results from a sudden injury or overuse, leading to pain, swelling, and difficulty moving the affected area. The severity of the rupture can vary, with partial tears causing less dysfunction than complete tears. Over time, the body attempts to heal the tendon, but the process can be slow and may not fully restore the tendon’s original strength or flexibility. Recovery often involves a combination of rest, physical therapy, and gradual return to activity. In some cases, surgical intervention may be necessary to repair the tendon.

Osteoporosis – This is a condition characterized by weakened bones that become fragile and more likely to fracture. It develops gradually over many years, often without symptoms until a fracture occurs. The disease is most common in older adults, particularly postmenopausal women, due to changes in hormone levels that affect bone density. As bones lose density, they become porous and brittle, increasing the risk of breaks from minor falls or even normal activities. The progression of osteoporosis can lead to a decrease in height, a stooped posture, and persistent back pain due to vertebral fractures. Maintaining bone health through diet and lifestyle is crucial in managing the condition.

Trial ID:
2024-519082-22-00
Protocol code:
ZORRO
NCT ID:
NCT03584542
Trial Phase:
Therapeutic exploratory (Phase II)

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