Watson Extraction System for Joint Replacement

(WES Trial)

CR
Overseen ByClinical Research Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new tool for individuals undergoing a second hip replacement surgery. The Watson Extraction System (WES) may simplify and enhance the safety of removing the old hip implant, potentially reducing surgery time and costs. Participants will undergo surgery using either the WES or the standard methods currently employed at The Ottawa Hospital. The trial seeks individuals who have had a hip replacement, require a revision, and possess a specific type of firmly fixed implant. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

What prior data suggests that the Watson Extraction System is safe for joint replacement surgery?

A previous study used the Watson Extraction System (WES) in a few cases, yielding promising results. The system appears to speed up the extraction process and reduce the need for more invasive procedures like extended trochanteric osteotomy (ETO), which can lead to complications. Health Canada's approval of the WES indicates a certain level of safety for human use. However, these studies do not provide specific data on negative effects or side effects. This trial aims to better understand how well people tolerate the WES compared to the current standard methods used at The Ottawa Hospital.12345

Why are researchers excited about this trial?

The Watson Extraction System (WES) is unique because it introduces a more streamlined process for stem extraction during joint replacement surgeries. Unlike the current standard of care, which relies on tools like K-wires, burrs, and flexible osteotomes based on surgeon preference, WES offers a consistent approach by utilizing its specialized device first. Researchers are excited about WES because it could potentially improve surgical outcomes by making the extraction process more efficient and reducing variability in surgical techniques.

What evidence suggests that the Watson Extraction System is effective for joint replacement?

Research has shown that the Watson Extraction System (WES), which participants in this trial may receive, has been tested in a few cases with promising results. The WES can reduce the time needed to remove the femoral stem, with some procedures taking only 6 to 18 minutes. This system also helps avoid more invasive surgeries, such as extended trochanteric osteotomy (ETO), which can lead to additional complications. Designed to be less invasive, the WES aims to preserve bone during the procedure. Although more research is needed to compare it directly to current methods, these early results are encouraging.678910

Are You a Good Fit for This Trial?

This trial is for adults who need revision hip replacement surgery to remove a previously implanted femoral stem. People with certain medical conditions or factors that would make the procedure unsafe may not be eligible.

Inclusion Criteria

Have well-fixed femoral components, of blade-stem design (collared and collarless)
I am over 18 years old.
I am having a repeat hip replacement surgery due to infection or other reasons.

Exclusion Criteria

My tapered stem implant has been in place for less than 4 months.
Femoral Stems with Trunnions greater than 14mm
Femoral Stems of alternative design not compatible for use with the WES
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo femoral stem extraction using either the Watson Extraction System or the current standard of care at TOH

1 day (surgery)
1 visit (in-person)

Follow-up

Participants are monitored for postoperative complications and changes in hip function and quality of life

3 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Watson Extraction System

Trial Overview

The study compares two ways of removing the femoral stem during hip revision surgery: the Watson Extraction System (a newer tool) versus standard extraction methods currently used at The Ottawa Hospital. Patients are randomly assigned to one method.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Watson Extraction System (WES)Experimental Treatment1 Intervention
Group II: Current Standard of Care at TOHActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

Citations

Watson Extraction System for Femoral Stem Extraction

Research shows that the WES has been studied in case series of a few people, and the results seem promising, reducing the time of extraction ...

The Watson Extraction System™️ delivered another great ...

The WES delivered an 18 minute extraction. The Watson Extraction SystemTM️ assisted in pulling another stem in 8 minutes! No ETO, and a ...

Removal of Well Fixed, Fluted Cementless Femoral Stem ...

In this study, we aimed to revisit and highlight the technique of antegrade drilling of the femur-stem interface during revision hip ...

Fracture risk during extraction of well-fixed extended ...

The concern of extensive fracturing and bone damage during implant removal has been reported for ingrowing stems, in particular in extended porous.

https://jnjinstitute.com/en-us/online-profed-resou...

No information is available for this page.

Comparative analysis of femoral bone loss: uncemented vs ...

Results Cemented stems were associated with a higher occurrence of significant bone defects of type 3a (23.53% vs. 14.02%, p = .108), 3b (39.22% ...

Socket Preservation Using Autogenous Bone Graft Versus ...

Studying the comparative effectiveness of socket preservation using autogenous bone graft versus MPM for implant insertion. Detailed Description.

(PDF) Hydroxyapatite-Coated Femoral Stems. Histological ...

The three patients had had a good or excellent clinical result and had died of causes unrelated to the joint arthroplasty. A coating of hydroxyapatite was ...

https://aahks.apprisor.org/epsAbstractAAHKS.cfm?id=1

No information is available for this page.

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