A.L.P.S. Plating System for Shoulder Fracture

Not currently recruiting at 10 trial locations

Overseen By Ryan Boylan, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Pregnancy, Alcohol abuse, Neurologic condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on evaluating the safety and effectiveness of the A.L.P.S. Proximal Humerus Plating System, a device used to fix shoulder fractures. It targets individuals with a specific type of shoulder fracture requiring surgery that has not healed with other treatments in the past three weeks. Suitable participants should be in good nutritional health and able to attend follow-up appointments. As an unphased trial, this study provides a unique opportunity to contribute to medical advancements and potentially benefit from innovative treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the A.L.P.S. Proximal Humerus Plating System is safe for shoulder fracture treatment?

Research shows that the A.L.P.S. Proximal Humerus Plating System aims to lower the risk of common problems in treating shoulder fractures. This system is already used for other bone issues, such as fractures and dislocations in the upper arm. Studies have found it effective for these conditions, indicating general safety. No specific reports of serious safety concerns suggest it is likely well-tolerated. As this study follows the product's approval for use, it further contributes to the system's safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The A.L.P.S. Proximal Humerus Plating System is unique because it offers a more anatomically contoured fit for shoulder fracture repairs compared to traditional plating systems. This precise fit can potentially lead to better alignment and healing outcomes. Additionally, its design may reduce the risk of soft tissue irritation, a common issue with other plating methods. Researchers are excited about this treatment because it could improve recovery times and patient comfort following shoulder fractures.

What evidence suggests that the A.L.P.S. Proximal Humerus Plating System is effective for shoulder fracture treatment?

Research has shown that the A.L.P.S. Proximal Humerus Plating System, which participants in this trial will receive, effectively treats shoulder fractures. In one study, all patients' bones healed, achieving "union," in about 15 weeks on average. Approximately 79% of these patients rated their results as satisfactory to excellent. Another study found that patients using the A.L.P.S. system regained shoulder movement, such as lifting the arm and rotating it outward, faster than with another treatment. These findings suggest that the A.L.P.S. system not only aids healing but also helps patients return to normal activities more quickly. ^{5 6 7 8 9}

Who Is on the Research Team?

Kacy Arnold, RN MBA

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a fresh shoulder fracture needing surgery, who can follow the study's procedures and are in good health. It's not for those with delayed surgery, mental conditions preventing consent, current substance abuse, active infections, poor bone quality or blood supply issues, sensitivity to foreign materials, prisoners or tumor-related fractures.

Inclusion Criteria

I need surgery for a major shoulder fracture and can be treated with plates and screws.

Patient must be able and willing to complete the protocol required follow-up.

Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent.

Exclusion Criteria

Patient is a prisoner.

My surgery has been postponed for over 3 weeks.

You have a sensitivity to foreign objects.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the A.L.P.S. Proximal Humerus Plating System for fracture fixation

Surgery and immediate post-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment, including shoulder range of motion and clinical efficacy assessments

2 years

What Are the Treatments Tested in This Trial?

Interventions

• A.L.P.S. Proximal Humerus Plating System

Trial Overview The A.L.P.S. Proximal Humerus Plating System is being tested for safety and performance in treating shoulder fractures. This multicenter study involves patients getting this specific plate-and-screw fixation treatment without randomization or control groups.

How Is the Trial Designed?

Group I: Patients who receive the A.L.P.S. Prox. Humerus Plating Sys. Experimental Treatment 1 Intervention

Subjects in need of proximal humerus fracture fixation who met the inclusion/exclusion criteria and received the A.L.P.S. Proximal Humerus Plating System. Subjects can be enrolled prospectively or retrospectively as indicated in the protocol.

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5842388/

Early Results of the A.L.P.S. Proximal Humerus Locking Plate Approximately 80% of proximal humerus fractures are stable and minimally displaced, and can be treated non-operatively [2, 3]. Operative options ...

2. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-06477-9

Comparison of the ALPS and PHILOS plating systems in ... The ALPS group showed better clinical outcomes with faster recovery in abduction and external rotation, although no difference in ROM remained after 21 months.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03626038?tab=table

Post Market Clinical Follow-up (PMCF) Study of the ... The A.L.P.S. Proximal Humerus Plating System was developed to provide another surgical option for proximal humerus fracture fixation. The aim of the A.L.P.S. ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29541270/

Early Results of the A.L.P.S. Proximal Humerus Locking Plate Results: Average follow-up was 31.9 weeks. Union was achieved in 100% of patients with a mean time to union of 15.1 weeks. In terms of function, mean OSS was ...

5. researchgate.net researchgate.net/publication/323578545_Early_Results_of_the_ALPS_Proximal_Humerus_Locking_Plate

Early Results of the A.L.P.S. Proximal Humerus Locking Plate Totally 43 patients (79%) had satisfactory to excellent results. Varus deformity was seen in 4 shoulders (8%) and the deformity of the greater ...

6. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/trauma/alps-proximal-humerus-plating-system.html

A.L.P.S® Proximal Humerus Plating System Proximal Humerus Plating System is designed to minimize the risk of some of the complications commonly associated with treating proximal humerus fractures.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03328650

Clinical Outcomes of the ALPS Proximal Humerus Plating ... The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System. Specific Aims: Conduct physical ...

8. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/education-resources/surgical-techniques/specialties/trauma/alps-proximal-humerus-plating-system/0035.4-GLBL-en%20PHP%20SurgTech-Digital1.pdf

A.L.P.S.® Proximal Humerus Plating System Proximal Humeral Plating. System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non- unions of the humerus, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10170861/

Comparison of the ALPS and PHILOS plating systems in ... Open reduction and plate osteosynthesis are considered as a successful technique for the treatment of proximal humerus fracture (PHF) ...