Robotic-Assisted Surgery for Hip Conditions

No longer recruiting at 1 trial location

Overseen By Lynsey D Boyle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Spinal surgery, Inflammatory arthritis, Infection, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a robotic tool in positioning hip implants during surgery. It targets individuals needing a primary total hip replacement due to conditions like osteoarthritis (joint pain and stiffness) or avascular necrosis (bone tissue death from lack of blood supply). Participants should not have had recent spine or lower body surgeries and should not be part of other joint pain studies. This trial suits those seeking a hip replacement through an anterior approach (surgery from the front of the hip) and who meet the criteria for using the robotic system (Robotic-Assisted Surgery). As an unphased trial, it offers participants the chance to contribute to innovative surgical advancements without the constraints of traditional clinical trial phases.

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

The trial protocol does not specify if you need to stop taking your current medications.

What prior data suggests that the robotic-arm surgical assistant (ROSA® Hip System) is safe for hip surgeries?

Research shows that surgeries using robotic systems, such as the ROSA® Hip System, are generally well-received by patients. Studies have found that these surgeries can lead to better outcomes than traditional methods. For instance, many patients report positive recovery experiences within the first 90 days after surgery.

Regarding safety, a review of various robotic systems used in hip surgeries found no major safety concerns. Patients who underwent these surgeries did not experience more complications than those who had regular surgeries. This suggests that robotic-assisted hip surgeries are safe.

Overall, the evidence indicates that robotic-assisted hip surgery is a safe option for patients. It is important to consult with a doctor to determine if this type of surgery is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic-assisted surgery for hip conditions because it offers greater precision and potentially better outcomes compared to traditional hip replacement methods. Unlike standard manual surgery, robotic systems like the ROSA Hip System enhance the surgeon's ability to position implants with high accuracy, which can lead to improved joint function and longevity of the hip replacement. Additionally, this technology may reduce recovery time and postoperative pain, making it a promising advancement for patients undergoing total hip arthroplasty (THA).

What evidence suggests that robotic-assisted surgery is effective for hip conditions?

Research has shown that using robots in total hip replacement surgery can lead to better results than traditional methods. One study found that patients who underwent robotic-assisted surgery felt better in the first 90 days after their operation. Another study demonstrated that patients reported even greater improvements one year after surgery with a robotic system. In this trial, participants will receive total hip arthroplasty (THA) via the ROSA® Hip System, a specific robotic tool that helps surgeons place hip implants more accurately, potentially leading to faster recovery and higher satisfaction. Overall, these findings suggest that robotic-assisted hip surgery can offer more precise operations and better outcomes for patients. ^{5 6 7 8 9}

Who Is on the Research Team?

Hillary Overholser

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with a BMI ≤40 kg/m2 who need a hip replacement due to conditions like osteoarthritis or avascular necrosis. Candidates must be suitable for the ROSA Hip System and able to consent. It's not open to those outside this age range, with higher BMI, or contraindications.

Inclusion Criteria

Body mass index ≤40 (BMI = kg/m2)

Patient is willing and able to provide informed consent

Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System

Exclusion Criteria

Would, in the Investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule

I have had spine or leg surgery, or joined a pain study recently or will soon.

I have a joint condition that is not osteoarthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Pre-operative data collection and preparation for surgery

1 week

1 visit (in-person)

Operative

Participants undergo the total hip arthroplasty using the ROSA Hip System

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for safety and effectiveness, including radiographic assessments and patient-reported outcomes

24 months

Multiple visits (in-person and virtual) at 3 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Avenir and Avenir Complete Systems
• Echo Bi-Metric System
• G7 Acetabular System
• Robotic Instrumentation
• Taperloc Complete System

Trial Overview The study tests the accuracy of hip implant placement using the ROSA® Hip System robot-assisted surgery. Participants will receive one of several specific hip implants (G7 Acetabular System, Taperloc Complete, Avenir Systems) through an anterior approach.

How Is the Trial Designed?

Group I: Robotic-Assisted THA Experimental Treatment 1 Intervention

Consecutive participants will receive THA via the ROSA Hip System.

Avenir and Avenir Complete Systems 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 Stem for:

• Total or hemi hip arthroplasty 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

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

The HipAlign® accelerometer-based navigation system significantly reduced postoperative leg length discrepancy (LLD) in patients undergoing total hip arthroplasty (THA), with more patients achieving an LLD within 5 mm compared to those using the freehand technique.

The navigation system's intraoperative measurements of leg length change were strongly correlated with postoperative radiographic measurements, indicating high accuracy and efficiency in minimizing surgical time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an accelerometer-based portable navigation for intraoperative adjustment of leg length discrepancy in total hip arthroplasty in the supine position. Anjiki, K., Kamenaga, T., Hayashi, S., et al.[2022]

The patient-specific instrumentation (PSI) system significantly improves the accuracy of prosthesis placement in total hip arthroplasty compared to traditional freehand methods, with smaller errors in acetabular cup anteversion and abduction.

While the PSI system is more accurate than freehand techniques, it is less precise than robotic systems, indicating that while PSI is a viable option, robotic assistance may offer the highest level of accuracy in hip surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Accuracy of a Patient-Specific Instrumentation System for Total Hip Arthroplasty. Zhang, T., Jia, Z., Han, W., et al.[2023]

The ROBODOC system, used in cementless total hip replacements, showed statistically better fit and positioning of the femoral component compared to traditional methods, as evaluated by radiographs in a study of 136 patients.

In a larger German study of 900 hip replacements, the ROBODOC system demonstrated a significant improvement in patient outcomes (Harris hip score increased from 43.7 to 91.5) and eliminated intraoperative femoral fractures, suggesting it is a safe and effective option for hip replacement surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary and revision total hip replacement using the Robodoc system. Bargar, WL., Bauer, A., Börner, M.[2022]

The study evaluated a minimally-invasive computer-navigated system (MICNS) for measuring limb length and femoral offset during total hip arthroplasty (THA) in 60 patients, demonstrating its effectiveness as an intraoperative tool.

The imageless, pinless navigation technique provided valid and accurate measurements, potentially improving surgical outcomes without the risks associated with radiation or invasive bone references.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative validation of navigated limb measurements in THA using a pinless femoral array. Ulivi, M., Orlandini, L., Pascale, W., et al.[2014]

The use of patient-specific instruments (PSI) in total hip arthroplasty (THA) significantly improves the precision of femoral prosthesis placement compared to the traditional free-hand approach, with smaller absolute errors in femoral anteversion (p < 0.001).

Despite the enhanced precision with PSI, there were no significant differences in operation time, blood loss, hospitalization duration, or recovery time, indicating that PSI is a feasible and reliable option for THA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and anteversion accuracy of a patient-specific instrument for femoral prosthesis implantation in total hip arthroplasty. Zheng, W., Liu, X., Mei, R., et al.[2023]

In a study of 44 patients undergoing total hip replacement, computer-assisted techniques were found to be effective in managing limb length discrepancies and restoring offset, despite longer surgical times compared to freehand techniques.

The use of navigated short modular femoral stems in total hip replacement is considered safe and beneficial for less invasive surgical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leg length discrepancy, dislocation rate, and offset in total hip replacement using a short modular stem: navigation vs conventional freehand. Confalonieri, N., Manzotti, A., Montironi, F., et al.[2009]

Robotic-assisted arthroplasty is becoming more common in clinical practice, with various systems available that differ in their technical features, including levels of autonomy and imaging methods used for guidance.

The review will compare leading robotic systems for hip endoprosthesis implantation, analyze learning curves for their use, and discuss cost models and future challenges in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Market overview: Robotic-assisted arthroplasty : Current robotic systems, learning curve and cost analysis]. Tuecking, LR., Ettinger, M., Windhagen, H., et al.[2022]

The EOS™ system demonstrated excellent reproducibility for lower-limb length measurements in a study of 112 patients, with both manual and automatic 3D methods achieving an intra-class coefficient greater than 0.98.

While both measurement methods were reliable, the automated 3D mode was preferred for collecting angular and offset measurements, indicating its potential for more precise evaluations in post-surgical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproducibility of length measurements of the lower limb by using EOS™. Clavé, A., Maurer, DG., Nagra, NS., et al.[2019]

In a study of 25 patients undergoing robotic-assisted total hip arthroplasty (THA), the Mako® system demonstrated precise and consistent implant positioning, with no increase in complications compared to traditional methods.

Post-surgery, patients showed significant functional improvement, with modified Harris scores rising from an average of 41.6 to 74.6 after four months, indicating effective recovery and enhanced mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Translated article] Clinical results of total hip arthroplasty assisted by robotic arm in Spain: Preliminary study. Rodríguez-González, FA., Bartrina-Tarrio, A., Gómez-Muñoz, E., et al.[2023]

The RomEo project aims to enhance total hip arthroplasty by integrating robotic assistance with minimally invasive techniques, potentially improving surgical accuracy and patient outcomes.

This development builds on previous robotic systems and addresses technical challenges, indicating a significant advancement in hip replacement surgery technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic systems in total hip arthroplasty--is the time ripe for a new approach? Mantwill, F., Schulz, AP., Faber, A., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12366894/

The clinical outcomes of robotic-assisted total hip ... Does robotic-assisted surgery improve outcomes of total hip arthroplasty compared to manual technique? A systematic review and meta-analysis ...

2. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/robotics/ROSA-Hip-Value-Analysis-Brief.pdf

ROSA® Hip Impact of Robotic. Assisted Surgery on Outcomes in Total Hip Arthroplasty. ... ROSA® Hip System for Robotically-Assisted Direct Anterior Total Hip Arthroplasty.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7784137/

Robotics in total hip arthroplasty: a review of the evolution ... This review aims to summarize the history and development of robotic technology in orthopaedic surgery, and discuss the evidence base surrounding its use.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352344124000785

Robot-Assisted Total Hip Arthroplasty Demonstrates ... The present study demonstrates favorable clinical and patient-reported outcomes in the first 90 days following surgery for patients undergoing robot-assisted ...

5. link.springer.com link.springer.com/article/10.1007/s00402-024-05230-8

Use of a fluoroscopy-based robotic-assisted total hip ... Use of a fluoroscopy-based robotic-assisted total hip arthroplasty system produced greater improvements in patient-reported outcomes at one year ...

6. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/zb-edge/robotics/rosa-hip-system.html

ROSA® Hip System A personalized robotic system that enables direct anterior surgeons to evaluate and execute a surgical plan based on real-time feedback and the patient's ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8693228/

Clinical and surgical outcomes of robot-assisted versus ... Robot-assisted total hip arthroplasty (THA), in comparison to conventional THA, improves radiographic outcomes, but it remains unclear ...

8. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-05279-6

Safety and efficacy of orthopedic robots in total hip arthroplasty This study aims to conduct a network meta-analysis to systematically evaluate the advantages of seven RA-THA systems.

9. journals.lww.com journals.lww.com/md-journal/fulltext/2025/08150/the_clinical_outcomes_of_robotic_assisted_total.62.aspx

The clinical outcomes of robotic-assisted total hip... The clinical outcomes of robotic-assisted total hip arthroplasty through the direct anterior approach: A meta-analysis and systematic review.