Avenir Complete Femoral Stem for Hip Arthritis

Not currently recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Avenir Complete Femoral Stem, a device used in hip replacement surgeries, to ensure its long-term safety and effectiveness. It targets individuals with severe hip issues, such as advanced arthritis or previous failed hip surgeries, who might benefit from a new hip implant. The study focuses on those with significant joint wear or conditions like avascular necrosis (loss of blood supply to bone tissue) of the hip. Participants must understand and follow medical advice and commit to follow-up check-ups. As an unphased trial, this study allows participants to contribute to important research that could enhance future hip replacement outcomes.

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 prior data suggests that the Avenir Complete Femoral Stem is safe for hip arthroplasty?

Research has shown that the Avenir Complete femoral stem, used in hip replacements, is safe. In one study, patients experienced good outcomes in hip function and appearance on X-rays over seven years. This suggests the hip implants functioned well and appeared normal, indicating no harm.

The implant also demonstrated durability over these seven years, meeting expectations for this type of treatment. This indicates that the Avenir Complete femoral stem is well-tolerated by patients undergoing hip replacements and does not cause major problems over time. Overall, the evidence supports the safety of this treatment for use in hip surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Avenir Complete Femoral Stem is unique because it introduces a novel design for hip replacements aimed at enhancing stability and longevity for patients with hip arthritis. Unlike traditional hip implants, which often focus on standard materials and shapes, the Avenir Complete Femoral Stem utilizes advanced materials and engineering to optimize the fit and integration with the patient’s bone. Researchers are excited about this treatment because its innovative approach has the potential to improve patient outcomes by reducing the risk of complications and the need for revision surgeries, making it a promising option for those with chronic hip issues.

What evidence suggests that the Avenir Complete Femoral Stem is effective for hip arthritis?

Research has shown that the Avenir Complete Femoral Stem is promising for treating hip arthritis. In past studies, patients who received this implant for hip replacement experienced good movement and excellent X-ray results over seven years. The implant also lasted well without needing replacement. These findings suggest that the femoral stem can improve hip function and offer long-term benefits for those undergoing hip joint replacement surgery. Participants in this trial will receive the Avenir Complete Femoral Stem implant to further evaluate its effectiveness and durability. ^{1 2 4 5 6}

Who Is on the Research Team?

Kacy Arnold, RN, MBA

Principal Investigator

Zimmer Biomet

Ryan Boylan

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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 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]

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]

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 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 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]

Citations

1. withpower.com withpower.com/trial/phase-osteoarthritis-9-2021-6086d

Avenir Complete Femoral Stem 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, ...

2. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/hip/avenir-complete-hip-system.html

Avenir Complete® Hip System Surgical Excellence. Fostering Operating Room efficiency and reproducible surgical technique, together with facilitating accurate and precise stem seating.

3. trials.arthritis.org trials.arthritis.org/trials/NCT04731077

Avenir Complete Post-Market Clinical Follow-Up Study The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30415580/

7-year results of primary total hip arthroplasty with the ... The 7-year implant survival and the functional outcomes for THA performed with the study device are excellent and were in line with those ...

5. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/hip/avenir-complete-femoral-hip-stem/HipAvenir112018.pdf

7-year results of primary total hip arthroplasty with the ... Aims: The aim of the present study was to evaluate the 7-year functional outcome and radiographic results of primary total hip arthroplasties (THAs) performed ...

6. withpower.com withpower.com/trial/phase-osteoarthritis-9-2021-6086d?condition=oa&ageList=65&overallStatus=Recruiting&hasNoPlacebo=false

Avenir Complete Femoral Stem 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, ...