Avenir Complete Femoral Stem for Hip Arthritis

Recruiting at 8 trial locations

Overseen By Linda Meijer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Infections, Muscular diseases, Bone tumors, 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: Surgical procedure

300 Participants Needed

Trial Summary

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 study team or your doctor.

What data supports the effectiveness of the Avenir Complete Femoral Stem treatment for hip arthritis?

The Avenir stem, used in hip replacements, showed good functional outcomes and radiographic results over 7 years in patients with hip arthritis. Additionally, similar femoral components have demonstrated long-term effectiveness and high survival rates in hip replacement surgeries. ^{1 2 3 4 5}

How is the Avenir Complete Femoral Stem treatment different from other hip arthritis treatments?

The Avenir Complete Femoral Stem is unique because it is an uncemented femoral stem used in total hip arthroplasty, which may offer better long-term outcomes by improving the fit against the medullary canal, potentially enhancing the durability and survivorship of the hip replacement. ^{2 3 6 7 8}

What is the purpose of this trial?

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.

Research Team

Kacy Arnold, RN, MBA

Principal Investigator

Zimmer Biomet

Ryan Boylan

Principal Investigator

Zimmer Biomet

Eligibility Criteria

This trial is for adults over 20 with advanced joint wear from conditions like osteoarthritis, or those who've had failed hip surgeries. Participants must understand and follow the study's instructions, consent to join, and commit to follow-up. Excluded are pregnant individuals, metal allergies, plans to relocate soon, certain diseases affecting implant success or those unable to comply.

Inclusion Criteria

My joint is severely damaged due to arthritis or injury.

I had hip surgery before that didn't work, including a hip replacement or surgery for a broken hip or dead bone tissue in the hip.

I am 20 years old or older and my bones have stopped growing.

Exclusion Criteria

Any concomitant diseases that can jeopardize the functioning and the success of the implant

Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.)

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Avenir Complete femoral stem implant

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety, performance, and clinical benefits of the implant

10 years

Annual visits (in-person)

Long-term Follow-up

Assessment of implant survival and patient-reported outcomes over 10 years

10 years

Treatment Details

Interventions

• Avenir Complete Femoral Stem

Trial Overview The Avenir Complete femoral stem is being tested in patients needing primary total hip replacement or revisions due to various joint issues. The study aims to confirm its long-term safety and effectiveness.

Participant Groups

Group I: Avenir Complete Femoral Stem Experimental Treatment 1 Intervention

All enrolled subjects receive the study implant

Avenir Complete Femoral Stem is already approved in United States, European Union for the following indications:

Approved in United States as Avenir Complete Hip System for:

• Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases
• Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR)
• Acute traumatic fracture of the femoral head or neck
• Avascular necrosis of the femoral head

Approved in European Union as Avenir Complete Hip System for:

• Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis
• Acute traumatic fracture of the femoral head or neck
• Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists

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 19 patients with Stage III avascular necrosis, treatment involving open reduction and methylmethacrylate cementation resulted in significant improvements in pain relief and hip function, as measured by various health scores over an average follow-up of 8.7 months.

While the procedure showed immediate benefits, including a notable increase in Harris Hip Scores from 54.0 to 79.5, the long-term effects on disease progression and the potential need for total hip arthroplasty in some patients remain uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open reduction and cementation for femoral head fracture secondary to avascular necrosis: preliminary report. Wood, ML., McDowell, CM., Kerstetter, TL., et al.[2018]

The 7-year survival rate for the uncemented Avenir stem in total hip arthroplasties was an impressive 98.9%, indicating excellent long-term efficacy and safety, with only one revision due to deep infection.

Functional outcomes were also strong, with a mean Harris Hip Score of 93.1 points at 7 years, suggesting that patients experienced significant improvement in hip function post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

7-year results of primary total hip arthroplasty with the uncemented Avenir stem. Erivan, R., Villatte, G., Brientini, JM., et al.[2022]

A new femoral stem design tailored to the unique geometrical features of the proximal femoral canals in Chinese patients with avascular necrosis shows improved stability compared to standard longer stems.

The study suggests that this novel stem may enhance bone ingrowth and long-term fixation of hip replacements, potentially reducing the failure rate of femoral components in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical comparisons between a new avascular necrosis of femaral head stem based on Chinese patients with avascular necrosis and two other designs. Zhang, Q., Cheng, CK., Wei, HW., et al.[2013]

In a study of 41 patients who underwent cementless total hip arthroplasty for advanced osteonecrosis, those without systemic diseases had a 100% ten-year survival rate of the femoral component, while those with systemic diseases had a significantly lower survival rate of 68%.

The findings suggest that the etiology of osteonecrosis impacts the longevity of the hip implant, with patients having systemic diseases being more likely to require stem revisions (15.4% of cases).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival of cementless femoral components after osteonecrosis of the femoral head with different etiologies. Radl, R., Egner, S., Hungerford, M., et al.[2005]

In a long-term study of 207 patients (104 with proximally coated and 103 with fully coated femoral components), both types of hip implants provided significant symptomatic relief, with similar revision rates of 96% for Group A and 94.8% for Group B over an average follow-up of 12.9 years.

While both implant types were effective, thigh pain was reported only in patients with proximally coated components, suggesting a potential safety concern specific to that design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary total hip arthroplasty with hydroxyapatite coated titanium femoral stems. Does design philosophy influence long term outcome?: Results of a prospective randomised controlled trial with follow-up of 10-15 years. Sandiford, NA., Skinner, JA., East, DJ., et al.[2015]

In a study of 203 patients with smooth-stemmed femoral components, 32 hips required revision due to mid-thigh pain and loose implants, indicating potential issues with implant stability.

At the two-year follow-up, the performance of completely cementless arthroplasties was comparable to hybrid prostheses, but the five-year survival rate was only 77%, suggesting that this type of implant should be used cautiously, particularly in patients where cement fixation is not an option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of 203 total hip replacements using a smooth, cementless femoral component. Duparc, J., Massin, P.[2020]

In a study of 162 patients with a mean follow-up of 84.5 months, the high offset collarless Corail femoral stem demonstrated no early failures or need for revision surgeries, indicating its safety and reliability in total hip arthroplasty.

The high offset stem effectively reproduced the native femoral offset with a mean difference of only -1.21mm, suggesting it is a suitable option for maintaining proper hip mechanics post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of a High Offset Fully Coated Collarless Cementless Stem Does Not Result in Early Failures in Total Hip Arthroplasty. Madhvani, KR., Hampton, M., Garneti, N.[2023]

In a study of 250 hybrid total hip arthroplasties performed over a 15-year period, the collarless, cemented Omnifit femoral stem showed a remarkable 100% survivorship rate, indicating excellent durability against mechanical failure.

The study highlights the importance of proper femoral component centralization and a good cement mantle, which contributed to the long-term success of the implant, with only one case (0.4%) requiring intervention for acetabular osteolysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fifteen-year survivorship of a collarless, cemented, normalized femoral stem in primary hybrid total hip arthroplasty with a modified third-generation cement technique. Rasquinha, VJ., Dua, V., Rodriguez, JA., et al.[2022]

References

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

Open reduction and cementation for femoral head fracture secondary to avascular necrosis: preliminary report. [2018]

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

7-year results of primary total hip arthroplasty with the uncemented Avenir stem. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Biomechanical comparisons between a new avascular necrosis of femaral head stem based on Chinese patients with avascular necrosis and two other designs. [2013]

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

Survival of cementless femoral components after osteonecrosis of the femoral head with different etiologies. [2005]

5. Belgium pubmed.ncbi.nlm.nih.gov

Primary total hip arthroplasty with hydroxyapatite coated titanium femoral stems. Does design philosophy influence long term outcome?: Results of a prospective randomised controlled trial with follow-up of 10-15 years. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Results of 203 total hip replacements using a smooth, cementless femoral component. [2020]

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

The Use of a High Offset Fully Coated Collarless Cementless Stem Does Not Result in Early Failures in Total Hip Arthroplasty. [2023]

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

Fifteen-year survivorship of a collarless, cemented, normalized femoral stem in primary hybrid total hip arthroplasty with a modified third-generation cement technique. [2022]