Computer-navigated THA Surgery for Total Hip Replacement

Overseen By Lyndsay Somerville

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Disqualifiers: Prior hip surgery, Prior spine surgery, Hip deformities, Spinal deformities, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve hip replacement surgeries using computer navigation and real-time modeling software (computer-navigated THA surgery). The goal is to help surgeons place hip implants more accurately, potentially leading to better satisfaction, pain relief, and functional improvement for patients. The study compares two groups: one using the new technology and one using the standard procedure. Individuals with hip osteoarthritis who haven't undergone previous hip or spine surgeries might be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this computer navigation system is safe for total hip arthroplasty?

Research has shown that computer guidance during total hip replacement surgery is safe. Studies have found that this technology helps doctors place the hip implant more accurately, reducing problems like dislocation or the need for additional surgery to fix or replace the implant.

Evidence suggests that with computer guidance, patients generally experience better outcomes. Specifically, there are fewer cases of hip dislocation and less need for future adjustments or replacements. This means the surgery is not only more precise but also safer for patients over time.

Overall, computer guidance in hip replacement surgery is well-accepted and can lower the risk of common issues associated with incorrect implant placement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about computer-navigated total hip arthroplasty (THA) surgery because it enhances the precision of implant placement. Unlike the standard procedure, which relies on the surgeon's experience and judgment, this technique uses advanced navigation software to plan the optimal position for the acetabular cup. This level of precision aims to improve outcomes by potentially reducing complications and extending the lifespan of the implant, leading to better long-term results for patients undergoing hip replacements.

What evidence suggests that computer-navigated THA surgery is effective for total hip replacement?

Research has shown that computer guidance in hip replacement surgery improves the accuracy of implant placement. In this trial, participants in the Prospective Computer-Navigated Cohort will receive standard implants with navigation software to plan optimal acetabular cup placement. One study found that without this technology, only 26% of hip implant parts were positioned correctly. In contrast, computer guidance improves placement, which is crucial for patient satisfaction and pain reduction. Additionally, using computers in surgery may speed up the operation and reduce costs. Overall, these findings suggest that computer-guided hip replacement could lead to better outcomes than traditional methods, which will be evaluated in the Cross-sectional Standard of Care Cohort of this trial. ^{2 6 7 8 9}

Who Is on the Research Team?

Brent Lanting, MD

Principal Investigator

London Health Sciences Centre/Lawson

Are You a Good Fit for This Trial?

This trial is for adults over 40 needing a hip replacement due to osteoarthritis, with a BMI under 40. They must be able to consent and follow study procedures. It's not for those with prior surgeries on the affected hip or lower spine, limited motion in the other hip, or certain spinal conditions.

Inclusion Criteria

Your body mass index (BMI) is less than 40 kg/m2.

40 years of age or older

You have hip osteoarthritis that requires a hip replacement surgery.

Exclusion Criteria

You have difficulty moving your hip on the opposite side of your body.

prior surgery on the indicated hip with insertion of hardware

You have had surgery on your lower spine that involved placing metal or other hardware.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Planning

Participants undergo pre-operative planning using computer navigation and real-time modeling software to optimize implant placement

1-2 weeks

Surgery

Participants undergo total hip arthroplasty with or without computer navigation assistance

1 day

Post-operative Follow-up

Participants are monitored for safety and effectiveness, including MRI and CT examinations to assess various outcomes

6 months

Multiple visits for imaging and assessments

What Are the Treatments Tested in This Trial?

Interventions

• Computer-navigated THA surgery
• Standard of care THA surgery

Trial Overview

The study compares traditional freehand total hip arthroplasty (THA) surgery with computer-navigated THA that uses real-time modeling software. The goal is to see if technology helps place implants more accurately and improves patient outcomes.

How Is the Trial Designed?

Group I: Prospective Computer-Navigated Cohort Experimental Treatment 1 Intervention

Patients in this arm will receive standard patient of care implants but navigation software will be used to plan optimal acetabular cup placement.

Group II: Cross-sectional Standard of Care Cohort Active Control 1 Intervention

Patients in this arm will receive standard of care implants and undergo standard of care procedure for total hip arthroplasty.

Standard of care THA surgery is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Total Hip Arthroplasty for:

• Severe hip arthritis
• Hip fractures
• Degenerative joint disease

Approved in United States as Total Hip Replacement for:

• Severe hip arthritis
• Hip fractures
• Degenerative joint disease
• Osteonecrosis

Approved in Canada as Total Hip Arthroplasty for:

• Severe hip arthritis
• Hip fractures
• Degenerative joint disease

Approved in Japan as Total Hip Arthroplasty for:

• Severe hip arthritis
• Hip fractures
• Degenerative joint disease

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Smith & Nephew, Inc.

Industry Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

Published Research Related to This Trial

A new customized total hip arthroplasty (THA) system uses 3D imaging from CT scans to create implants that match a patient's unique anatomy, potentially improving surgical outcomes compared to conventional methods.

This personalized approach aims to restore femoral offset and version, reducing risks of complications like dislocation and fractures, and enhancing the longevity and functionality of the implant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THA with Use of Patient-Specific Resurfacing Jigs and a Novel Customized Implant Design. Zinner, M., Schroeder, L., Pumilia, CA., et al.[2023]

In a study of total hip arthroplasty (THA) patients, nearly one-third of adverse events occurred between 31 and 90 days post-surgery, indicating that monitoring should extend beyond the typical 30-day window.

The study found that women and patients with higher comorbidity scores were more likely to experience these later adverse events, suggesting that these factors should be considered in patient risk assessments and postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events After Total Hip Arthroplasty are not Sufficiently Characterized by 30-Day Follow-Up: A Database Study. Maloy, GC., Kammien, AJ., Rubin, LE., et al.[2023]

The study analyzed data from 6,912 primary total hip arthroplasties (THAs) performed in Australia from 2009 to 2019, finding that computer navigation significantly reduced the rate of revision for dislocation, with a 10-year cumulative revision rate of 0.4% for navigated THAs compared to 0.8% for non-navigated THAs.

Additionally, for the five most commonly used prosthesis combinations with navigation, the rate of all-cause revision was lower in navigated THAs (2.4%) compared to non-navigated THAs (4.2%), indicating that computer navigation may enhance the overall effectiveness of THA procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Computer Navigation in Total Hip Arthroplasty Is Associated with a Reduced Rate of Revision for Dislocation: A Study of 6,912 Navigated THA Procedures from the Australian Orthopaedic Association National Joint Replacement Registry. Agarwal, S., Eckhard, L., Walter, WL., et al.[2023]

Most adverse events following total hip arthroplasty (THA) are rare and can often be prevented or easily managed, highlighting the overall safety of the procedure.

Cardiovascular complications, such as myocardial infarction and thromboembolism, can occur during or after THA, indicating the need for careful monitoring of patients with pre-existing heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total hip arthroplasty and cardiovascular complications: a review. Taheriazam, A., Saeidinia, A., Keihanian, F.[2022]

Computer-navigated total hip arthroplasty (THA) showed improved accuracy in placing the acetabular component, resulting in fewer outliers compared to conventional techniques, based on a meta-analysis of clinical trials.

However, the use of computer navigation was associated with longer operation times, indicating a trade-off between precision and efficiency in the surgical process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based computer-navigated total hip arthroplasty: an updated analysis of randomized controlled trials. Li, YL., Jia, J., Wu, Q., et al.[2022]

In a study of 1809 Medicare beneficiaries who underwent total hip arthroplasty (THA) from 2002 to 2007, the overall rate of adverse events was found to be 5.8%, with increased age and obesity identified as significant risk factors.

The annual rate of adverse events decreased significantly from 9.1% in 2002 to 3.0% in 2007, indicating improvements in perioperative care, although the reasons for this decline remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age and obesity are risk factors for adverse events after total hip arthroplasty. Huddleston, JI., Wang, Y., Uquillas, C., et al.[2022]

In a study of 1911 total hip arthroplasty (THA) procedures using the Intellijoint HIP navigation system, the 2-year cumulative percent revision (CPR) rate was 1.8%, which is comparable to the 2.2% CPR rate for both other navigated systems and nonnavigated procedures, indicating similar effectiveness in preventing revisions.

However, when analyzing specific prosthesis types, the combination of the Paragon/Acetabular Shell THAs with the Intellijoint system showed a higher revision rate of 3.4%, suggesting that certain combinations may require further investigation for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Revision Rates of Total Hip Arthroplasty Using the Intellijoint HIP Computer Navigation System: A Study From the Australian National Joint Replacement Registry of 1911 Procedures. Lourens, EC., Kurmis, AP., Holder, C., et al.[2022]

Total hip arthroplasty (THA) is a highly effective surgery for alleviating pain and improving quality of life in patients with end-stage hip osteoarthritis, especially when conservative treatments have failed.

Successful outcomes from THA are linked to realistic patient expectations and thorough preoperative education about the risks and benefits, emphasizing the importance of an interdisciplinary approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indications for joint replacement : Total hip arthroplasty]. Rahm, S., Zingg, PO.[2019]

In a study of 72 patients undergoing computer-navigated revision total hip arthroplasty (rTHA), there were no dislocations reported at 3 months, 1 year, and 2 years post-surgery, indicating a significant reduction in dislocation rates compared to previous primary THA procedures where 31% experienced dislocations.

The use of computer navigation in rTHA may improve the alignment of femoral and acetabular components, which is crucial in preventing dislocations, suggesting that this technology could enhance surgical outcomes in hip replacement surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer Navigation for Revision Total Hip Arthroplasty Reduces Dislocation Rates. Sharma, AK., Cizmic, Z., Carroll, KM., et al.[2023]

In a study analyzing 59,938 total hip arthroplasties (THA) from 2010 to 2020, imageless navigation did not show a reduction in 90-day postoperative adverse events compared to traditional methods, with the exception of a higher incidence of wound dehiscence in the navigation group.

At the 5-year mark, the revision rates were higher for the navigated group (4.4%) compared to the non-navigated group (3.6%), indicating that imageless navigation may not provide long-term benefits in THA outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total Hip Arthroplasty Imageless Navigation Does Not Reduce 90-Day Adverse Events or Five-Year Revisions in a Large National Cohort. Jayaram, RH., Gillinov, SM., Caruana, DL., et al.[2023]

Total hip arthroplasty (THA) is a widely accepted surgical procedure for treating hip joint disorders, indicating its established role in improving patient outcomes.

The procedure has shown significant efficacy in restoring mobility and reducing pain in patients, making it a common choice for those suffering from severe hip issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total Hip Arthroplasty: So Hip It Hurts. Holzer, LA.[2023]

The use of an imageless navigation device during Total Hip Arthroplasty (THA) added only an average of 2.9 minutes to the surgical time, which is minimal compared to the potential benefits it offers.

There was no significant difference in overall procedural time between surgeries using the navigation system and those using standard mechanical guides, suggesting that the navigation tool can be effectively integrated without extending surgery duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal Increase in Total Hip Arthroplasty Surgical Procedural Time with the Use of a Novel Surgical Navigation Tool. Christ, A., Ponzio, D., Pitta, M., et al.[2022]

Computer-guided total hip arthroplasty (THA) significantly reduced the revision rate compared to non-computer-guided THA, with a 10-year cumulative revision rate of 1.06% versus 3.88%, indicating improved long-term outcomes.

While patient-reported outcome measures (PROMs) did not show significant differences between the two groups, patient satisfaction was higher in the computer-guided group, suggesting potential benefits in patient experience despite the observational nature of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Risk of Revision with Computer-Guided Versus Non-Computer-Guided THA: An Analysis of Manufacturer-Specific Data from the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man. Davis, ET., McKinney, KD., Kamali, A., et al.[2022]

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Computer-navigated THA Surgery for Total Hip Replacement

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