Osteoarthritis of the KneeNCT02373761
A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement
An observational study of Osteoarthritis of the Knee, run by Scott Sporer at 1 site in United States.
Trial summary
This study seeks to find out if the tibial and patellar components of the Stryker Triathlon Tritanium primary total knee replacement achieve adequate fixation to the underlying bone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Stryker Triathlon Tritanium primary knee
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2019
- How long will I take part?
- 2 Years
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample of patients undergoing total knee replacement with the Triathlon Tritanium knee components at Central DuPage Hospital.
Who may be able to join
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Scheduled to undergo a total knee arthroplasty
- Patients between the ages of 18 and 80, inclusive
- Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling
Who cannot join
- Significant co-morbidity affecting ability to ambulate
- Prior arthroplasty, patellectomy or osteotomy with the affected knee
- Active or prior infection of the affected knee
- Morbid obesity (BMI > 40)
- Medical condition precluding major surgery
- Severe osteoporosis
Show all 17Show fewer
- Neuromuscular impairment
- Pregnancy
- Inability to give informed consent
- Inability to return for follow-up visits for a minimum of two years after surgery
- Currently participating in any other surgical intervention study
- Known allergy to metals
- Flexion contracture greater than 15°
- Extension lag greater than 10°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Lateral or medial collateral ligament instability (> 10° varus/valgus)
- Leg length discrepancy greater than 10 mm
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to find out if the tibial and patellar components of the Stryker Triathlon Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.
Read the detailed description
Primary Hypothesis:
The investigators expect the tibial and patellar components of the Stryker Triathlon Tritanium knee to achieve adequate fixation to the underlying bone.
Secondary Hypotheses:
The investigators expect that there will be no continuous migration between one and two years post-operative in the Triathlon Tritanium components.
The investigators expect to see a correlation between radiolucent lines and migration characteristics using RSA.
The investigators expect that inducible displacement exams taken at 2 years post-operative will be able to distinguish between patients identified by RSA measurements as having inadequate fixation.
The investigators expect to see a significant difference in health status and functional outcomes before and after total knee replacement using the Triathlon Tritanium knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Stryker Triathlon Tritanium primary knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryker Triathlon Tritanium primary kneeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years.
Measured: 3 years
Secondary outcomes (1)
Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Scott Sporer
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor-investigator, Scott Sporer, Central DuPage Hospital
- Investigators
- Scott Sporer, MD, Principal investigator, Central DuPage Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373761
- Sponsor's protocol ID
- 15-034-CDH
- Status last verified
- Feb 2015
- First submitted
- 13 Feb 2015
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.
PubMed 7744919Pijls BG, Valstar ER, Nouta KA, Plevier JW, Fiocco M, Middeldorp S, Nelissen RG. Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop. 2012 Dec;83(6):614-24. doi: 10.3109/17453674.2012.747052. Epub 2012 Nov 9.
PubMed 23140091
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement
- ClinicalTrials.gov ID
- NCT02373761
- Acronym / sponsor ID
- 15-034-CDH
- Conditions
- Osteoarthritis of the Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Scott SporerUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Feb 2015
- Primary completion
- Feb 2019 (estimated)
- First posted
- 27 Feb 2015 (estimated)
- 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.
This study seeks to find out if the tibial and patellar components of the Stryker Triathlon Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.
Detailed description
Primary Hypothesis:
The investigators expect the tibial and patellar components of the Stryker Triathlon Tritanium knee to achieve adequate fixation to the underlying bone.
Secondary Hypotheses:
The investigators expect that there will be no continuous migration between one and two years post-operative in the Triathlon Tritanium components.
The investigators expect to see a correlation between radiolucent lines and migration characteristics using RSA.
The investigators expect that inducible displacement exams taken at 2 years post-operative will be able to distinguish between patients identified by RSA measurements as having inadequate fixation.
The investigators expect to see a significant difference in health status and functional outcomes before and after total knee replacement using the Triathlon Tritanium knee.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample of patients undergoing total knee replacement with the Triathlon Tritanium knee components at Central DuPage Hospital.
Key inclusion criteria (4 listed)
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Scheduled to undergo a total knee arthroplasty
- Patients between the ages of 18 and 80, inclusive
- Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling
Key exclusion criteria (17 listed)
- Significant co-morbidity affecting ability to ambulate
- Prior arthroplasty, patellectomy or osteotomy with the affected knee
- Active or prior infection of the affected knee
- Morbid obesity (BMI > 40)
- Medical condition precluding major surgery
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 |
|---|---|---|
| Stryker Triathlon Tritanium primary knee | Device | – |
Primary outcome
Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years.
Time frame: 3 years
1 secondary outcome
Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Results publication: PubMed 7744919Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.
- Results publication: PubMed 23140091Pijls BG, Valstar ER, Nouta KA, Plevier JW, Fiocco M, Middeldorp S, Nelissen RG. Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop. 2012 Dec;83(6):614-24. doi: 10.3109/17453674.2012.747052. Epub 2012 Nov 9.
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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.
Scott Sporer, MD principal investigator
Central DuPage Hospital
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 Osteoarthritis of the Knee, run by Scott Sporer 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 17 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: status not confirmed, as of the sponsor's last update on 27 Feb 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Sporer, MD (630-933-6254, scottsporer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373761, which also lists 2 linked publications.
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 27 Feb 2015.