Watson Extraction System for Femoral Stem Extraction

NCT07836608 | Not Yet Recruiting

• 1 other identifier: 20260480-01H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A revision total hip replacement surgery requires the surgeon to remove, or extract, the femoral stem (the rod that was placed into the thigh bone during your first hip replacement). A variety of tools and techniques can be used to do this. At The Ottawa Hospital (TOH) surgeons attempt to remove the stem using less invasive measures, such as osteotomes, a tool that separates the stem from the bone, but if it doesn't work, they may need to perform an extended trochanteric osteotomy (ETO). An ETO is more invasive and increases the risk of complications. The Watson Extraction System (WES) is another Health Canada approved tool that goes around the stem to help remove the femoral stem from the thigh bone. 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 and need for ETO. However, it is not clear if it offers better results than what is currently done at TOH. The purpose of this study is to compare the WES to the current/usual care care at TOH to determine whether the WES can remove the femoral stem more efficiently (in less time and at a lower hospital cost) and effectively, while improving patient safety.

Conditions

Revision Arthroplasty

Outcome Measures

Primary Outcomes (2)

• Timing of surgery

  The time it take to complete the surgery, including the femoral stem extraction

  From surgery start to surgery close

• Time of Femoral Stem Extraction

  Amount of time, in minutes, it takes to remove the femoral stem during surgery

  From start of femoral stem extraction to end of femoral stem extraction, up to 60 minutes

Secondary Outcomes (6)

• Intraoperative complication rate

  From surgery start to surgery close

• Postoperative Complication Rate

  From end of surgery to 3 months postoperative

• Change in Patient-report Hip function from baseline to 3 months

  Baseline and at 3 month following surgery

• Change in Health Related Quality of Life from Baseline to 3 months

  At baseline and 3 months after surgery

• Cost of OR time and resources

  From start of surgery to end of surgery

Study Arms (2)

Watson Extraction System (WES)

EXPERIMENTAL

Participants randomized to this arm will undergo stem extraction utilizing the WES in addition to other standard of care equipment, as required. Surgeons will use the WES device for extraction first.

Device: Watson Extraction System

Current Standard of Care at TOH

ACTIVE COMPARATOR

Participants randomized to this arm will undergo stem extraction as per surgeon preference with the use of K-wires, burr and flexible osteotomes. An ETO will be performed as per surgical judgement.

Procedure: Standard of Care Stem Extraction

Interventions

Watson Extraction System DEVICE

The Watson Extraction System is a surgical instrumentation system used to facilitate femoral stem extraction during revision total hip arthroplasty. Participants randomized to the intervention group will undergo femoral stem extraction using the Watson Extraction System.

Watson Extraction System (WES)

Standard of Care Stem Extraction PROCEDURE

Femoral stem extraction will occur using standard surgical techniques and instrumentation routinely available for revision total hip arthroplasty.

Current Standard of Care at TOH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Undergoing revision Total Hip Arthroplasty for septic or aseptic indications
• Have well-fixed femoral components, of blade-stem design (collared and collarless)

You may not qualify if:

• Tapered stem in situ less than 4 months
• Cemented Stems
• Femoral Stems with Trunnions \> 14mm
• Femoral Stems of alternative design not compatible for use with the WES

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Central Study Contacts

Clinical Research Coordinator

CONTACT

613-737-8899; meadufresne@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)