Voll fully degradable shoulder spacer for massive rotator cuff tears
A Multi-Center, Prospective, First-In-Human Study to Evaluate the Initial Safety and Effectiveness of a Degradable Shoulder Spacer in Patients With Symptomatic Massive Rotator Cuff Tears
This will try a fully degradable shoulder spacer in people aged 50 and older with symptomatic massive rotator cuff tears to see if it is safe and helps shoulder pain and function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Voll Medical Technologies Ltd. Industry-sponsored |
| Locations | 4 sites (Ashdod and 3 other locations) |
| Trial ID | NCT07208448 on ClinicalTrials.gov |
What this trial studies
This is a first‑in‑human, interventional study of a fully degradable subacromial shoulder spacer implanted in patients with symptomatic full‑thickness massive rotator cuff tears. The device is placed surgically to create a temporary mechanical buffer in the subacromial space, with follow‑up visits to monitor safety, device degradation, and clinical outcomes such as pain and shoulder function. Eligible patients are adults aged 50 or older in generally good health who can comply with postoperative follow‑up; key exclusions include recent drug or alcohol abuse and participation in other investigational studies. The trial is being conducted at sites in Israel and Italy and will collect perioperative and serial clinical outcome data to characterize early safety and performance.
Who should consider this trial
Good fit: Ideal candidates are people aged 50 or older with symptomatic full‑thickness massive rotator cuff tears who are in generally good health and able to attend postoperative follow‑up visits.
Not a fit: Patients with a documented history of drug or alcohol abuse within the past year, those enrolled in other investigational studies, people medically unfit for surgery, or those with smaller or different shoulder pathologies are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the degradable spacer could reduce pain and improve shoulder function for patients with MRCT while avoiding a permanent implant or more invasive reconstruction.
How similar studies have performed: Biodegradable subacromial spacers have been tested before with mixed results, and this device represents a first‑in‑human test of Voll's specific degradable spacer design.
Eligibility criteria
Show full inclusion / exclusion criteria
Main Inclusion Criteria: * Full thickness MRCT. * Male or female patients ≥ fifty (50) years of age, in general good health, independent, and can comply with all post-operative evaluations and visits. Main Exclusion Criteria: * Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment. * Concurrent participation in any other investigational clinical study.
Where this trial is running
Ashdod and 3 other locations
- Assuta Ashdod Hospital — Ashdod, Israel (Recruiting)
- Ichilov (Sourasky Medical Center) — Tel Aviv, Israel (Not_yet_recruiting)
- Humanitas Gavazzeni Castelli — Bergamo, Bergamo, Italy (Not_yet_recruiting)
- Istituto Ortopedico Rizzoli — Bologna, Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.