Arthroplasty, Replacement, KneeNCT02178020
Outcome Study of Highly-cross Linked Polyethylene vs. Standard Polyethylene for Primary Posterior Stabilized (PS) Total Knee
An observational study of Arthroplasty, Replacement, Knee, run by Chapel Hill Orthopedics Surgery & Sports Medicine at 1 site in United States.
Trial summary
Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced to decrease this problem, but there is little data on the results and complications of this polyethylene in posterior-stabilized knee… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- knee arthroplasty, standard polyethylene and knee arthroplasty, XLP polyethylene
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2019
- How long will I take part?
- 10 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all female and male patients with arthritis of knee that requires total knee arthroplasty
Who may be able to join
- all patients indicated for primary total posterior stabilized knee arthroplasty
Who cannot join
- patients who refused participation
- patients who did not comprehend the English language to give informed consent
- patients with severe knee deformity thought to require a primary constrained condylar prosthesis
Trial locations and contacts
1 site in 1 country.
United States1 site
Chapel Hill Orthopedic Surgery and Sports Medicine
Chapel Hill, North Carolina, 27514
About this study
Official title: Prospective, Randomized Study of Highly-cross Linked Polyethylene vs. Compression Molded Polyethylene for Primary Posterior-stabilized Total Knee Arthroplasty
Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced to decrease this problem, but there is little data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following questions: (1) Are there any differences in the clinical and radiographic results when a highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency of reoperation in these two groups and are there any specific complications related to highly cross-linked polyethylene liners.
Read the detailed description
This prospective, randomized study will seek to enroll patients undergoing primary total knee arthroplasty. Preoperative evaluation will include a detailed history and physical exam with clinical data collection (SF-36, WOMAC, and Knee Society Scores), a complete description of the procedure, a demonstration of the actual types of implants and tibial inserts, and an outline of the study protocol and informed consent. Intraoperatively, the patient will undergo a total knee arthroplasty utilizing standard operative procedures. Each patient will receive a Zimmer NexGen posterior-stabilized total knee arthroplasty. During the procedure or preoperative visit, the patient will be randomized by sealed envelope to receive either a standard Zimmer UHMWPE tibial insert or a Zimmer highly cross-linked UHMWPE tibial insert. Both surgeon and patient will be blinded to the type of implant used. there will be no variations in surgical technique and hospital management of the patients throughout the course of the study. Postoperatively, the patient will be seen for routine follow-up at six weeks, 6 months, 1 year and yearly thereafter. Radiographs will be obtained at each visit. Clinical data forms will be completed at each visit. At the conclusion of the study radiographs will be assessed for signs of polyethylene wear, osteolysis and component loosening. the preoperative and postoperative knee scores will be calculated for each patient and compared between the patient groups with standard statistical analysis.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- knee arthroplasty, standard polyethylene, knee arthroplasty, XLP polyethylene
- Keywords
- Knee Arthroplasty, Osteolysis, Radiolucent Lines
- Medical subject headings
- Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee arthroplasty, standard polyethyleneDevice
Also called Zimmer
total knee replacement follow-up; clinical and radiographic; revision rate
knee arthroplasty, XLP polyethyleneDevice
Also called Zimmer: Prolong
total knee arthroplasty with highly crosslinked polyethylene tibial liner
| Study group | Role | What they receive |
|---|---|---|
| knee arthroplasty, standard polyethylene | total knee arthroplasty with Standard Compression Molded tibial Polyethylene Liner Receives: Device: knee arthroplasty, standard polyethylene | |
| knee arthroplasty, Highly Cross-Linked (XLP) polyethylene | knee arthroplasty with Highly Cross-Linked tibial Polyethylene Liner Receives: Device: knee arthroplasty, XLP polyethylene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants requiring revision, or with Device Related Serious Adverse Events
reoperation rate; polyethylene fracture/failure rate
Measured: Up to 10 years
Radiographic osteolysis
lucent, periarticular lesions , related to polyethylene wear
Measured: up to 10 years
Secondary outcomes (2)
knee scores
Knee Society Pain and Function scores
Measured: up to 10 years
knee joint effusion
knee joint examination
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJul 2009
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, 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-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Chapel Hill Orthopedics Surgery & Sports Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Paul F Lachiewicz, MD, Principal investigator, Chapel Hill Orthopedic Surgery and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178020
- Sponsor's protocol ID
- 05017.0501399RC05
- Status last verified
- Jan 2017
- First submitted
- 23 Jun 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study of Highly-cross Linked Polyethylene vs. Compression Molded Polyethylene for Primary Posterior-stabilized Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02178020
- Acronym / sponsor ID
- 05017.0501399RC05
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Knee Arthroplasty, Osteolysis, Radiolucent Lines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chapel Hill Orthopedics Surgery & Sports MedicineUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Jul 2009
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 30 Jun 2014 (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.
Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced to decrease this problem, but there is little data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following questions: (1) Are there any differences in the clinical and radiographic results when a highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency of reoperation in these two groups and are there any specific complications related to highly cross-linked polyethylene liners.
Detailed description
This prospective, randomized study will seek to enroll patients undergoing primary total knee arthroplasty. Preoperative evaluation will include a detailed history and physical exam with clinical data collection (SF-36, WOMAC, and Knee Society Scores), a complete description of the procedure, a demonstration of the actual types of implants and tibial inserts, and an outline of the study protocol and informed consent. Intraoperatively, the patient will undergo a total knee arthroplasty utilizing standard operative procedures. Each patient will receive a Zimmer NexGen posterior-stabilized total knee arthroplasty. During the procedure or preoperative visit, the patient will be randomized by sealed envelope to receive either a standard Zimmer UHMWPE tibial insert or a Zimmer highly cross-linked UHMWPE tibial insert. Both surgeon and patient will be blinded to the type of implant used. there will be no variations in surgical technique and hospital management of the patients throughout the course of the study. Postoperatively, the patient will be seen for routine follow-up at six weeks, 6 months, 1 year and yearly thereafter. Radiographs will be obtained at each visit. Clinical data forms will be completed at each visit. At the conclusion of the study radiographs will be assessed for signs of polyethylene wear, osteolysis and component loosening. the preoperative and postoperative knee scores will be calculated for each patient and compared between the patient groups with standard statistical analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knee arthroplasty, standard polyethylene | – | Device: knee arthroplasty, standard polyethylenetotal knee arthroplasty with Standard Compression Molded tibial Polyethylene Liner |
| knee arthroplasty, Highly Cross-Linked (XLP) polyethylene | – | Device: knee arthroplasty, XLP polyethyleneknee arthroplasty with Highly Cross-Linked tibial Polyethylene Liner |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all female and male patients with arthritis of knee that requires total knee arthroplasty
Key inclusion criteria (1 listed)
- all patients indicated for primary total posterior stabilized knee arthroplasty
Key exclusion criteria (3 listed)
- patients who refused participation
- patients who did not comprehend the English language to give informed consent
- patients with severe knee deformity thought to require a primary constrained condylar prosthesis
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 |
|---|---|---|
| knee arthroplasty, standard polyethyleneAlso: Zimmertotal knee replacement follow-up; clinical and radiographic; revision rate | Device | knee arthroplasty, standard polyethylene |
| knee arthroplasty, XLP polyethyleneAlso: Zimmer: Prolongtotal knee arthroplasty with highly crosslinked polyethylene tibial liner | Device | knee arthroplasty, Highly Cross-Linked (XLP) polyethylene |
Primary outcome
Number of Participants requiring revision, or with Device Related Serious Adverse Events
Time frame: Up to 10 years
reoperation rate; polyethylene fracture/failure rate
Radiographic osteolysis
Time frame: up to 10 years
lucent, periarticular lesions , related to polyethylene wear
2 secondary outcomes
knee scores
Time frame: up to 10 years
knee joint effusion
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
Paul F Lachiewicz, MD principal investigator
Chapel Hill Orthopedic Surgery and Sports Medicine
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 Arthroplasty, Replacement, Knee, run by Chapel Hill Orthopedics Surgery & Sports 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 1 inclusion and 3 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 1 Feb 2017. 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?
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?
Number of Participants requiring revision, or with Device Related Serious Adverse Events (time frame: Up to 10 years). 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 1 Feb 2017.