NCT07208448

Brief Summary

The Voll Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a degradable shoulder spacer in over 50 years old patients with symptomatic massive rotator cuff tears (MRCT).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

September 18, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 9, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

September 18, 2025

Last Update Submit

March 5, 2026

Conditions

Massive Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

  • Device-related Serious Adverse Events

    Incidence of device-related serious adverse events (DRSAEs) related to the spacer.

    Up to 12 months post-implantationץ

Study Arms (1)

Voll Degradable Shoulder Spacer

EXPERIMENTAL
Device: Voll Degradable Shoulder Spacer

Interventions

Voll Degradable Shoulder SpacerDEVICE

Voll Degradable Shoulder Spacer

Voll Degradable Shoulder Spacer

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
  • Concurrent participation in any other investigational clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Assuta Ashdod Hospital

Ashdod, Israel

RECRUITING

Ichilov (Sourasky Medical Center)

Tel Aviv, Israel

NOT YET RECRUITING

Humanitas Gavazzeni Castelli

Bergamo, Bergamo, 24125, Italy

NOT YET RECRUITING

Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2025

First Posted

October 6, 2025

Study Start

December 9, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)IT(2)