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

Trial Summary

What is the purpose of this trial?

Replacing diseased hip joints with prosthetic implants in a procedure called total hip arthroplasty (THA) is associated with high rates of patient satisfaction, pain relief, and functional improvement when the implant is appropriately placed. Incorrect implant size or placement may lead to a breadth of negative outcomes, which could result in the need for implant revision. It is difficult to assess the precise orientation of patient hips on the operating table, with one study revealing that only 26% of acetabular cups placed without technological assistance are correctly positioned. Using computer navigation as a guide to achieve optimal implant alignment may improve successful placement rates. The additional incorporation of real-time modeling software may further help realize higher rates of successful implant placement. This study, therefore, aims to investigate a computer navigation system coupled with real-time modeling software to establish the benefit of such technology in the operating room, and further improve positive patient outcomes following THA. We hypothesize that including technological assistance in THAs will yield better patient outcomes compared to surgeries performed freehand.

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 data supports the effectiveness of the treatment Computer-navigated THA surgery for Total Hip Replacement?

Research shows that using computer navigation in total hip replacement surgery can lead to more accurate placement of the hip components, which is associated with a reduced rate of needing another surgery due to dislocation or other issues. ^{1 2 3 4 5}

Is computer-navigated total hip replacement surgery safe?

Computer-navigated total hip replacement surgery is generally considered safe, with most adverse events being uncommon and preventable or easily treated. However, like any major surgery, there are risks of complications such as heart issues or blood clots, especially in older or obese patients. ^{3 6 7 8 9}

How is computer-navigated THA surgery different from standard hip replacement treatments?

Computer-navigated THA surgery uses advanced technology to guide the surgeon in placing hip components more accurately, which can reduce the risk of complications like dislocation. This approach is different from traditional methods that rely heavily on the surgeon's experience and skill without technological assistance. ^{4 10 11 12 13}

Research Team

Brent Lanting, MD

Principal Investigator

London Health Sciences Centre/Lawson

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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 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]

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States 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. [2022]

3. United States 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. [2022]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Minimal Increase in Total Hip Arthroplasty Surgical Procedural Time with the Use of a Novel Surgical Navigation Tool. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Indications for joint replacement : Total hip arthroplasty]. [2019]

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

Adverse Events After Total Hip Arthroplasty are not Sufficiently Characterized by 30-Day Follow-Up: A Database Study. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Total hip arthroplasty and cardiovascular complications: a review. [2022]

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

Age and obesity are risk factors for adverse events after total hip arthroplasty. [2022]

9. United States 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. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Computer Navigation for Revision Total Hip Arthroplasty Reduces Dislocation Rates. [2023]

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

THA with Use of Patient-Specific Resurfacing Jigs and a Novel Customized Implant Design. [2023]

12. France pubmed.ncbi.nlm.nih.gov

Evidence-based computer-navigated total hip arthroplasty: an updated analysis of randomized controlled trials. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Total Hip Arthroplasty: So Hip It Hurts. [2023]