Revision ArthroplastyWESNCT07836608
Watson Extraction System for Femoral Stem Extraction
A study testing Watson Extraction System in people with Revision Arthroplasty, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Arthroplasty
- What is being tested?
- Watson Extraction System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Clinical Research Coordinator, 613-737-8899 ext. 73032, meadufresne@ohri.ca
About this study
Official title: Is Use of the Watson Extraction System Associated With Reduced Operative Time and Safer Stem Extraction? - A Randomized Controlled Trial
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
- Being tested
- Watson Extraction System, Standard of Care Stem Extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watson Extraction SystemDevice
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.
Standard of Care Stem ExtractionProcedure or surgery
Femoral stem extraction will occur using standard surgical techniques and instrumentation routinely available for revision total hip arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard of Care Stem Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of surgery
The time it take to complete the surgery, including the femoral stem extraction
Measured: 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
Measured: From start of femoral stem extraction to end of femoral stem extraction, up to 60 minutes
Secondary outcomes (6)
Intraoperative complication rate
Proportion of participants experiencing an intraoperative complication related to femoral stem extraction, including femoral fracture, cortical perforation, or extended trochanteric osteotomy use.
Measured: From surgery start to surgery close
Postoperative Complication Rate
Proportion of participants experiencing a postoperative complication or require a reoperation relating to the hip revision.
Measured: From end of surgery to 3 months postoperative
Change in Patient-report Hip function from baseline to 3 months
Participants will complete the Oxford Hip Score to assess hip function, where 0 is worse possible hip function and 48 is best hip function.
Measured: Baseline and at 3 month following surgery
Change in Health Related Quality of Life from Baseline to 3 months
Participants will complete the EQ-5D-5L to assess health related quality of life, where an index scores range from -0.573 to 1.00, with higher scores indicating better health related quality of life.
Measured: At baseline and 3 months after surgery
Cost of OR time and resources
Unit costs of OR time and resources, as per institutional financial data and standard costing sources.
Measured: From start of surgery to end of surgery
Cost of complications
Unit cost of complications derived from institutional financial data and standard costing sources
Measured: From end of surgery to 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836608
- Sponsor's protocol ID
- 20260480-01H
- Acronym
- WES
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Use of the Watson Extraction System Associated With Reduced Operative Time and Safer Stem Extraction? - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07836608
- Acronym / sponsor ID
- WES / 20260480-01H
- Conditions
- Revision Arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Watson Extraction System (WES) | Experimental | Device: Watson Extraction SystemParticipants 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. |
| Current Standard of Care at TOH | Active comparator | Procedure: Standard of Care Stem ExtractionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watson Extraction SystemThe 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. | Device | Watson Extraction System (WES) |
| Standard of Care Stem ExtractionFemoral stem extraction will occur using standard surgical techniques and instrumentation routinely available for revision total hip arthroplasty. | Procedure or surgery | Current Standard of Care at TOH |
Primary outcome
Timing of surgery
Time frame: From surgery start to surgery close
The time it take to complete the surgery, including the femoral stem extraction
Time of Femoral Stem Extraction
Time frame: From start of femoral stem extraction to end of femoral stem extraction, up to 60 minutes
Amount of time, in minutes, it takes to remove the femoral stem during surgery
6 secondary outcomes
Intraoperative complication rate
Time frame: From surgery start to surgery close
Postoperative Complication Rate
Time frame: From end of surgery to 3 months postoperative
Change in Patient-report Hip function from baseline to 3 months
Time frame: Baseline and at 3 month following surgery
Change in Health Related Quality of Life from Baseline to 3 months
Time frame: At baseline and 3 months after surgery
Cost of OR time and resources
Time frame: From start of surgery to end of surgery
Cost of complications
Time frame: From end of surgery to 3 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watson Extraction System in people with Revision Arthroplasty, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (613-737-8899 ext. 73032, meadufresne@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of surgery (time frame: From surgery start to surgery close). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.