Osteoarthritis, KneeNCT01132365
Knee Arthroplasty Registry
An observational study of Osteoarthritis, Knee, run by Heekin Orthopedic Research Institute at 1 site in United States.
Trial summary
Objective Describe the clinical and demographic characteristics of patients who undergo knee arthroplasty and document post operative outcomes. Examine the relationship between processes of care, hospital and surgeon associated outcomes. Read more about this study
- Who is it for?
- Ages 21 to 93 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- any knee joint arthroplasty device
- Type of treatment
- Medical device
- How many people
- 7,793 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Dec 2018
- 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 21 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All male and non-pregnant females undergoing knee arthroplasty.
Who may be able to join
- Patient is a male or non-pregnant female over the age of 21.
- Patient requires a knee arthroplasty, revision knee arthroplasty, or unicondylar knee arthroplasty
- Patient has signed and dated an IRB approved consent form.
- Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
- Patient has failed to respond to conservative treatment modalities.
Who cannot join
- Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
- Patient is a prisoner.
Trial locations and contacts
1 site in 1 country.
United States1 site
Heekin Orthopedic Specialists
Jacksonville, Florida, 32204
About this study
Official title: Knee Arthroplasty Registry a. Function and Survival Stratified by BMI b. Return of Quadriceps Strength After Primary TKA
Objective
Describe the clinical and demographic characteristics of patients who undergo knee arthroplasty and document post operative outcomes.
Examine the relationship between processes of care, hospital and surgeon associated outcomes.
Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients.
Analyze and design ancillary studies to address unanswered questions.
Disseminate findings through publication in peer-reviewed scientific journals.
Read the detailed description
Population: All male and non-pregnant females undergoing knee arthroplasty.
Study Design: Prospective, consecutive series on an unlimited number of patients.
Data Collection
Clinic Data:
Patient Demographics- age, weight, height, gender, affected side, co-morbidities, current medications, and contact information Knee Society Score SF-12 Evaluation of radiographs- AP, ML, and merchant view Preop lab results
Surgical Data:
Surgical approach ASA level Size of implants, catalog and lot numbers Time of surgery Estimated blood loss (ml) Length of incision (cm) Intraoperative ROM Any peculiar findings (i.e. heterotopic bone, large osteophytes, etc.) Preop lab results
Postoperative Data Sf-12 Modified Knee Society Score Quad strength testing Evaluation of radiographs, AP, ML, and merchant view
- Conditions
- Osteoarthritis, Knee
- Being tested
- any knee joint arthroplasty device
- Keywords
- knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
any knee joint arthroplasty deviceDevice
Also called Total Knee Arthoplasty, Unicondylar Knee arthroplasty, Revision Knee Arthroplasty
Cohort consist of all consented patients receiving knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| knee arthroplasty | Not described Receives: Device: any knee joint arthroplasty device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startApr 2005
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,793 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heekin Orthopedic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics, Stryker Orthopaedics, Restor3D
- Responsible party
- Principal investigator, R. David Heekin, MD, Heekin Orthopedic Research Institute
- Investigators
- Richard D Heekin, MD, Principal investigator, Heekin Orthopedic Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132365
- Sponsor's protocol ID
- 05-05-02
- Status last verified
- Jul 2016
- First submitted
- 26 May 2010
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Arthroplasty Registry a. Function and Survival Stratified by BMI b. Return of Quadriceps Strength After Primary TKA
- ClinicalTrials.gov ID
- NCT01132365
- Acronym / sponsor ID
- 05-05-02
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,793 participants (estimated)
- Lead sponsor
- Heekin Orthopedic Research InstituteUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics, Stryker Orthopaedics, Restor3D
- Study start
- Apr 2005
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 May 2010 (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.
Objective
Describe the clinical and demographic characteristics of patients who undergo knee arthroplasty and document post operative outcomes.
Examine the relationship between processes of care, hospital and surgeon associated outcomes.
Provide expanded data to characterize existing and evolving practice patterns, delivery of care, and resource utilization in the management of knee arthroplasty patients.
Analyze and design ancillary studies to address unanswered questions.
Disseminate findings through publication in peer-reviewed scientific journals.
Detailed description
Population: All male and non-pregnant females undergoing knee arthroplasty.
Study Design: Prospective, consecutive series on an unlimited number of patients.
Data Collection
Clinic Data:
Patient Demographics- age, weight, height, gender, affected side, co-morbidities, current medications, and contact information Knee Society Score SF-12 Evaluation of radiographs- AP, ML, and merchant view Preop lab results
Surgical Data:
Surgical approach ASA level Size of implants, catalog and lot numbers Time of surgery Estimated blood loss (ml) Length of incision (cm) Intraoperative ROM Any peculiar findings (i.e. heterotopic bone, large osteophytes, etc.) Preop lab results
Postoperative Data Sf-12 Modified Knee Society Score Quad strength testing Evaluation of radiographs, AP, ML, and merchant view
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| knee arthroplasty | – | Device: any knee joint arthroplasty device |
Who may qualify
- Ages
- 21 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All male and non-pregnant females undergoing knee arthroplasty.
Key inclusion criteria (5 listed)
- Patient is a male or non-pregnant female over the age of 21.
- Patient requires a knee arthroplasty, revision knee arthroplasty, or unicondylar knee arthroplasty
- Patient has signed and dated an IRB approved consent form.
- Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
- Patient has failed to respond to conservative treatment modalities.
Key exclusion criteria (2 listed)
- Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
- Patient is a prisoner.
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 |
|---|---|---|
| any knee joint arthroplasty deviceAlso: Total Knee Arthoplasty, Unicondylar Knee arthroplasty, Revision Knee ArthroplastyCohort consist of all consented patients receiving knee arthroplasty | Device | knee arthroplasty |
Primary outcome
Knee Society Score
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
Richard D Heekin, MD principal investigator
Heekin Orthopedic Specialists
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, Knee, run by Heekin Orthopedic Research Institute 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 5 inclusion and 2 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 26 Jul 2016. 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?
Knee Society Score (time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1, 2, 5, 10 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 26 Jul 2016.