Affixus Nail System for Broken Arm

Recruiting at 4 trial locations

Overseen By Richard J Marek, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Infection, Skeletal immaturity, Mental conditions, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Surgery day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Affixus Nail System treatment for broken arms?

Research on similar intramedullary nail systems for humeral fractures suggests that these treatments can be effective, with favorable outcomes compared to traditional methods. However, complications can occur, and more high-quality studies are needed to confirm these findings. ^{1 2 3 4 5}

Is the Affixus Nail System generally safe for use in humans?

The Zimmer Natural Nail System, which is similar to the Affixus Nail System, has shown good union rates and low complication rates in initial studies, but there have been reports of implant failure and complications like nail breakage and impingement in some cases. ^{5 6 7 8 9}

What makes the Affixus Nail System treatment unique for broken arm treatment?

The Affixus Nail System is unique because it uses an intramedullary (inside the bone) interlocking mechanism to stabilize fractures, which can be less invasive compared to traditional methods. This system is designed to provide stability without the need for the nail to jam into the bone, potentially reducing complications associated with other treatments. ^{1 2 6 8 10}

Research Team

Hassan Achakri, Ph.D.

Principal Investigator

Director Clinical Affairs

Eligibility Criteria

This trial is for adults over 18 with a broken upper arm bone needing surgery, who can follow the study's procedures and have agreed to participate. It's not for those with certain bone conditions, infections, mental or neurologic issues that prevent consent, pregnancy, or if they're unlikely to complete the study.

Inclusion Criteria

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

I understand my surgeon's explanations, can follow instructions, and agree to participate in follow-ups.

Exclusion Criteria

Not expected to survive the duration of the follow-up program

My bone is abnormally curved or deformed.

I have a fracture near my elbow.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery for the implantation of the Affixus Natural Nail System Humeral Nail

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for safety, performance, and clinical benefits, including bone union, functional outcomes, and adverse events

12 months

Regular follow-up visits as per study protocol

Treatment Details

Interventions

• Affixus Natural Nail System

Trial Overview The Affixus Natural Nail System is being tested in patients with specific types of arm fractures. The study aims to confirm its safety and effectiveness when used in surgical repair of these fractures.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Subject target population suffers from fractures or osteotomies of the humerus which require temporary fixation and stabilization.

Affixus Natural Nail System is already approved in United States, European Union for the following indications:

Approved in United States as Affixus Natural Nail System Humeral Nail for:

• Proximal fractures (proximal short and long nails only)
• Diaphyseal fractures (proximal long, antegrade/retrograde nails)
• Open and closed fractures
• Comminuted fractures
• Nonunions and malunions
• Pathologic fractures

Approved in European Union as Affixus Natural Nail System Humeral Nail for:

• Proximal fractures (proximal short and long nails only)
• Diaphyseal fractures (proximal long, antegrade/retrograde nails)
• Open and closed fractures
• Comminuted fractures
• Nonunions and malunions
• Pathologic fractures

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

Findings from Research

In a study of 111 patients with humeral shaft fractures treated with intramedullary (IM) nails over 10 years, nearly half experienced intra-operative complications, highlighting the need for careful technique to minimize risks.

The use of second generation IM nails was associated with significantly lower rates of both intra-operative and postoperative complications compared to first generation nails, leading to better functional outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications after interlocking intramedullary nailing of humeral shaft fractures. Baltov, A., Mihail, R., Dian, E.[2022]

The study analyzed the outcomes of intramedullary (IM) nail fixation for proximal humerus fractures (PHFs) in 60 patients, showing that the average surgical time significantly decreased as surgeons gained experience (p = .002).

While IM nailing is a promising treatment option for two-part PHFs, it was found that three- and four-part fractures had a higher complication rate (53% vs. 20%), indicating that the complexity of the fracture affects the safety and efficacy of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption of Intramedullary Nail Fixation for Proximal Humerus Fractures: Assessment of Surgical Efficiency and Complications. Ponce, BA., Williams, JF., Watson, SL., et al.[2019]

The Fixion™ expandable nailing system for humeral fractures shows a non-union rate of 7.8% and low device failure rates (1.1% intra-operative and 2.8% post-operative), suggesting it may be a safe and effective treatment option compared to traditional locked humeral nails.

Despite promising initial results, the evidence is limited by methodological flaws, including a lack of comparative studies and blinding, indicating that further high-quality research is necessary to validate the efficacy of the expandable nailing system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expandable intramedullary nails for humeral fractures: a systematic review of clinical and radiological outcomes. Rose, DM., Smith, TO., Nielsen, D., et al.[2021]

Interlocking humeral nail systems improve the treatment of humeral shaft fractures by providing better rotational control and allowing for axial loading, which can enhance healing without the need for bone grafting in closed nailing procedures.

These nails are particularly effective for various fracture types, including segmental and pathologic fractures, with union rates comparable to traditional methods like compression plates, while minimizing surgical trauma and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intramedullary nailing of humeral shaft fractures. Pickering, RM., Crenshaw, AH., Zinar, DM.[2005]

In a study of 28 patients with humeral fractures, both anterograde and retrograde nailing techniques showed similar subjective outcomes in terms of function, pain, and range of motion, indicating comparable efficacy.

However, 50% of patients in the anterograde nailing group experienced subacromial impingement leading to reoperation, suggesting that this approach may have a higher risk of complications compared to retrograde nailing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Antegrade or retrograde intramedullary nailing in diaphyseal or sub-capital humeral fractures in the adult]. Togninalli, D., Remiger, A.[2016]

Two cases of broken tail portions of the Zimmer Natural Nail® (ZNN) lag screw during removal procedures were reported, highlighting a potential complication associated with this implant.

This complication may lead to significantly prolonged operation times if the necessary tools for addressing the issue are not readily available, emphasizing the importance of preparedness during surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breakage of the Tail Portion of the Lag Screw during Removal of Proximal Femoral Zimmer Natural Nail: Report of Two Cases with Technical Notes. Santoso, A., Choi, IS., Park, KS., et al.[2020]

In a study of 156 Hispanic patients who underwent cephalomedullary nailing, factors such as female gender, the use of straight and short nails, and a greater angle of incidence of the femur were significantly associated with anterior cortical impingement, with the angle of incidence being a strong predictor of impingement risk.

The study suggests that using a posterior entry site for nail insertion increases the risk of impingement, and recommends that an anterior entry site be used along with a specific nail design tailored for the Hispanic population to reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cephalomedullary nails: factors associated with impingement of the anterior cortex of the femur in a Hispanic population. Peña, OR., Gómez Gélvez, A., Espinosa, KA., et al.[2021]

In a study of 201 patients aged 81 on average, 5% experienced nail breakages with the Cephalomedullary Nail (CMN), particularly at the lag screw junction, indicating a notable risk of implant failure over time.

Due to the observed increase in implant failures, the study prompted a change to a 130° CMN implant and a thicker guide wire for better stability, highlighting the need for ongoing monitoring and adjustments in surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The learning curve with a new cephalomedullary femoral nail. Fine, NF., Sexton, SA., Williams, DH.[2018]

In a study of 59 elderly patients with intertrochanteric fractures, the proximal femoral nail antirotation (PFNA) was found to have a shorter average operation time (62.7 minutes) compared to the Zimmer natural nail (ZNN) (73.6 minutes), indicating that PFNA may be easier to use in surgical settings.

Both PFNA and ZNN showed similar outcomes in terms of bleeding, fracture healing time, postoperative complications, and hip function scores, suggesting that both implants are effective for treating these types of fractures in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of the effects of two cephalomedullary nails (zimmer natural nail and proximal femoral nail antirotation) in treatment of elderly intertrochan teric fractures]. Chen, J., Zuo, CH., Zhang, CY., et al.[2023]

The study compared two interlocking nailing systems for treating humeral shaft fractures: the Seidel-nail and the unreamed humeral nail (UHN), involving 47 patients treated with the Seidel-nail and 34 patients with the UHN.

The UHN showed better outcomes with fewer complications, allowing for both anterograde and retrograde insertion, and providing better fracture compression and rotational stability, making it the recommended choice for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intramedullary fixation of humerus shaft fractures. An analysis of complications of 2 implants with special reference to outcome after management with the unreamed humerus interlocking nail]. Vécsei, N., Kolonja, A., Mousavi, M., et al.[2016]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Complications after interlocking intramedullary nailing of humeral shaft fractures. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Adoption of Intramedullary Nail Fixation for Proximal Humerus Fractures: Assessment of Surgical Efficiency and Complications. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Expandable intramedullary nails for humeral fractures: a systematic review of clinical and radiological outcomes. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Intramedullary nailing of humeral shaft fractures. [2005]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Antegrade or retrograde intramedullary nailing in diaphyseal or sub-capital humeral fractures in the adult]. [2016]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Breakage of the Tail Portion of the Lag Screw during Removal of Proximal Femoral Zimmer Natural Nail: Report of Two Cases with Technical Notes. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Cephalomedullary nails: factors associated with impingement of the anterior cortex of the femur in a Hispanic population. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The learning curve with a new cephalomedullary femoral nail. [2018]

9. China pubmed.ncbi.nlm.nih.gov

[Comparison of the effects of two cephalomedullary nails (zimmer natural nail and proximal femoral nail antirotation) in treatment of elderly intertrochan teric fractures]. [2023]

10. Austria pubmed.ncbi.nlm.nih.gov

[Intramedullary fixation of humerus shaft fractures. An analysis of complications of 2 implants with special reference to outcome after management with the unreamed humerus interlocking nail]. [2016]