Arthroplasties, Knee ReplacementNCT03272178
Impact of Component Design and Fixation in Total Knee Arthroplasty
An observational study of Arthroplasties, Knee Replacement, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroplasties, Knee Replacement
- What is being tested?
- Depuy total knee implant and Triathlon total knee implant
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 15 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A. Patients who qualify for a Primary Total Knee Arthroplasty using Stryker Triathlon Implant(thin tray) or Depuy Attune(thick tray) Implant
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Arthroplasties, Knee Replacement
- Being tested
- Depuy total knee implant, Triathlon total knee implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depuy total knee implantDevice
patients from Dr Nunley's clinic will get a Depuy implant
Triathlon total knee implantDevice
patients from Dr Barrack's clinic will get a Triathlon implant
| Study group | Role | What they receive |
|---|---|---|
| Triathlon knee total knee arthroplasty | 50 Patients who are assigned to Triathlon knee, half cemented/half cementless Receives: Device: Triathlon total knee implant | |
| Depuy knee total knee arthroplasty | 50 Patients who are assigned to Depuy knee, half cemented/half cementless Receives: Device: Depuy total knee implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone density
Patients will have a DEXA scan to look for change in bone loss at 6 weeks, 1 year, and 2 year to determine bone loss patterns and geometry
Measured: 2 years
Secondary outcomes (6)
knee society score
Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Measured: 2 years
Forgotten joint score
Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Measured: 2 years
Oxford knee score
Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Measured: 2 years
UCLA Activity score
UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Measured: 2 years
SF-12
SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Measured: 2 years
EQ-5D
EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start20 Nov 2017
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasties, Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272178
- Sponsor's protocol ID
- 201708094
- Status last verified
- Nov 2021
- First submitted
- 22 Aug 2017
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Component Design and Fixation in Bone Remodeling After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03272178
- Acronym / sponsor ID
- 201708094
- Conditions
- Arthroplasties, Knee Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 5 Sep 2017 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triathlon knee total knee arthroplasty | – | Device: Triathlon total knee implant50 Patients who are assigned to Triathlon knee, half cemented/half cementless |
| Depuy knee total knee arthroplasty | – | Device: Depuy total knee implant50 Patients who are assigned to Depuy knee, half cemented/half cementless |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A. Patients who qualify for a Primary Total Knee Arthroplasty using Stryker Triathlon Implant(thin tray) or Depuy Attune(thick tray) Implant
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Depuy total knee implantpatients from Dr Nunley's clinic will get a Depuy implant | Device | Depuy knee total knee arthroplasty |
| Triathlon total knee implantpatients from Dr Barrack's clinic will get a Triathlon implant | Device | Triathlon knee total knee arthroplasty |
Primary outcome
Change in bone density
Time frame: 2 years
Patients will have a DEXA scan to look for change in bone loss at 6 weeks, 1 year, and 2 year to determine bone loss patterns and geometry
6 secondary outcomes
knee society score
Time frame: 2 years
Forgotten joint score
Time frame: 2 years
Oxford knee score
Time frame: 2 years
UCLA Activity score
Time frame: 2 years
SF-12
Time frame: 2 years
EQ-5D
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasties, Knee Replacement, run by Washington University School of Medicine at 1 site in United States.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 1 Dec 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone density (time frame: 2 years). 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 1 Dec 2021.