Impact of Component Design and Fixation in Total Knee Arthroplasty
Status: | Enrolling by invitation |
---|---|
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 5/5/2018 |
Start Date: | November 20, 2017 |
End Date: | January 2020 |
Impact of Component Design and Fixation in Bone Remodeling After Total Knee Arthroplasty
The purpose of this study is to determine implant design and determine if method of fixation
cemented versus cementless results in different bone loss patterns. The investigators also
want to determine if clinical outcomes correlate with bone density changes.
cemented versus cementless results in different bone loss patterns. The investigators also
want to determine if clinical outcomes correlate with bone density changes.
Patients who present to the clinical practices of Dr. Ryan Nunley and Dr. Robert Barrack and
are suitable candidates for primary total knee arthroplasty(TKA) type assigned either
cemented or cementless and Triathlon knee or Depuy by surgeon will be screened for
eligibility and invited to participate. Data collected for the study will include standard of
care clinical and radiographic evaluations collected during office visits and surgery, Dual
Energy X-Ray Absorptiometry(DEXA) Bone density monitoring, as well as study-specific patient
questionnaires. Clinical, radiographic and questionnaire data will be collected
pre-operatively, at the time of surgery, and at 6 weeks, 1 year and beyond, and 2 years and
beyond post-operatively. Patients will complete the following outcomes questionnaires
preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and
EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one
year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten
Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee
Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing.
are suitable candidates for primary total knee arthroplasty(TKA) type assigned either
cemented or cementless and Triathlon knee or Depuy by surgeon will be screened for
eligibility and invited to participate. Data collected for the study will include standard of
care clinical and radiographic evaluations collected during office visits and surgery, Dual
Energy X-Ray Absorptiometry(DEXA) Bone density monitoring, as well as study-specific patient
questionnaires. Clinical, radiographic and questionnaire data will be collected
pre-operatively, at the time of surgery, and at 6 weeks, 1 year and beyond, and 2 years and
beyond post-operatively. Patients will complete the following outcomes questionnaires
preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and
EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one
year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten
Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee
Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing.
Inclusion Criteria:
- Patients who qualify for a Primary Total knee using Triathlon Implant(thin tray) or
Depuy Attune(thick tray) Implant
- 18-75 years of age
- Willing to sign informed consent
- Willing to return for all follow-up visits
Exclusion Criteria:
- Patients with inflammatory arthritis
- BMI > 40
- Patient with an active infection or suspected infection in the joint
- Patient who have undergone osteotomy
- Patients who have a previous diagnosis of osteopenia/osteoporosis or patients with
weak bones and/or currently on medications to increase bone density/who have poor bone
quality
- Patients who have had previous patella fracture or surgery
- Patients who have had previous knee or hip replacement surgery on the ipsilateral side
- Patients who require patellar resurfacing
- Patient with major medical/muscular/orthopedic deformities
- Unable to undergo DEXA scanning.
- Female patients of childbearing potential and an interest in getting pregnant in the
future *NOTE: Patients receiving simultaneous bilateral total knee arthroplasties are
eligible. Both knees are eligible for enrollment as long as all other
inclusion/exclusion criteria are met for each knee. If only one knee is eligible it
will be included. Patients receiving staged bilaterals are also eligible, provided
that each knee meets the inclusion exclusion criteria.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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