Health TrialsbyHealthPanel

Watson Extraction System for Femoral Stem Extraction

ConditionRevision Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard of Care Stem Extraction

    Procedure/Surgery

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Watson Extraction System (WES)Experimental treatment 1 intervention
Group B: Current Standard of Care at TOHActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Timing of surgery

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

Time frame
From surgery start to surgery close
2

Time of Femoral Stem Extraction

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

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

Secondary outcomes

1

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.

Time frame
From surgery start to surgery close
2

Postoperative Complication Rate

Proportion of participants experiencing a postoperative complication or require a reoperation relating to the hip revision.

Time frame
From end of surgery to 3 months postoperative
3

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.

Time frame
Baseline and at 3 month following surgery
4

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.

Time frame
At baseline and 3 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: