Osteoarthritis, KneeNCT02362867
Balanced Knee System Clinical Protocol for IRB Approval
A study testing Balanced Knee System in people with Osteoarthritis, Knee and Rheumatoid Arthritis of Knee, run by Ortho Development Corporation.
Trial summary
The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Post-traumatic Osteoarthritis of Knee Nos
- What is being tested?
- Balanced Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to 2 Jun 2019
- Phase
- Interventional
- 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
Who may be able to join
- Loss of joint configuration and joint function.
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint.
- Post-traumatic arthritis of the knee joint.
- Moderate valgus, varus, or flexion deformities.
Who cannot join
- Any patient not experiencing a compromised quality of life by loss of joint function and/or joint configuration, or pain from arthritis disease.
- Any patient whose knee cannot be returned to normal function and normal stability through reconstructive procedures, including ligamentous balancing.
- Active infection in or near the knee joint, fever and/or local inflammation signs, and elevation of sedimentation rate unexplained by other diseases should not be treated unless preoperative infection is ruled out.
- Distant foci of infection, such as genitourinary, pulmonary, skin (chronic lesions or ulcerations), and other sites, which may result in hematogenous spread to the implant site.
- Rapid joint destruction or bone absorption apparent on roentgenograms.
- Neuromuscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits gained by the patient from usage of the prosthesis.
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- Mental disorders which would compromise essential patient post-operative care.
- A painless, stable arthrodesis in a functional position.
- Allergic reactions to implant materials, and/or tissue reactions to the products of corrosion or wear.
- Skeletal immaturity.
- Any patient who is unwilling or unable to comply with post-operative instructions or clinical study requirements.
About this study
The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.
Read the detailed description
The rationale is based on the potential effectiveness of the BKS to:
- Return patient to normal activities or increase mobility by restoring knee function.
- Provide stability to enhance rehabilitation without external support.
- Eliminate or reduce knee pain.
- Assess the clinical efficacy after total knee replacement.
- Determine implant survivorship and viability.
- Evaluate patient function and satisfaction.
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Post-traumatic Osteoarthritis of Knee Nos, Valgus Deformity
- Being tested
- Balanced Knee System
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced Knee SystemDevice
Also called BKS
A multi-compartmental total knee replacement providing a system of components for primary posterior cruciate ligament substituting procedures. The system consists of femoral, tibial, and patellar components that allow the surgeon to select the most appropriate component combination to meet specific patient needs.
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Replacement | No intervention | Total knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as osteoarthritis, rheumatoid arthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, or complications from a previous prosthesis. The Balanced Knee System (BKS) will be used to treat patients undergoing a total knee replacement. Receives: Device: Balanced Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate effectiveness of the BKS by assessing complications during surgery and the post-operative follow-up period
Measured: 1-10 years
Secondary outcomes (3)
Assess the effectiveness of the BKS by analyzing radiographic evidence and clinical data.
Measured: 1-10 years
Identify any surveillance issues regarding the device design and surgical approach used refinement of the surgical technique
Measured: 1-10 years
Evaluate device performance through the use of the Knee Society Score, Short Form-36 Health Survey, and radiographic evaluation.
Measured: 1-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startJan 2003
- Primary completion2 Jun 2019
- Study completion2 Jun 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Mark's Hospital, Salt Lake Orthopaedic Clinic
- Responsible party
- Sponsor
- Investigators
- Michael H. Bourne, M.D., Principal investigator, Salt Lake Orthopaedic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362867
- Sponsor's protocol ID
- R-07-0017
- Status last verified
- Sep 2021
- First submitted
- 9 Feb 2015
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced Knee System Clinical Protocol for IRB Approval
- ClinicalTrials.gov ID
- NCT02362867
- Acronym / sponsor ID
- R-07-0017
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis of Knee, Post-traumatic Osteoarthritis of Knee Nos, Valgus Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ortho Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- St. Mark's Hospital, Salt Lake Orthopaedic Clinic
- Study start
- Jan 2003 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 2 Jun 2019 (actual)
- First posted
- 13 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.
The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.
Detailed description
The rationale is based on the potential effectiveness of the BKS to:
- Return patient to normal activities or increase mobility by restoring knee function.
- Provide stability to enhance rehabilitation without external support.
- Eliminate or reduce knee pain.
- Assess the clinical efficacy after total knee replacement.
- Determine implant survivorship and viability.
- Evaluate patient function and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Knee Replacement | No intervention | Device: Balanced Knee SystemTotal knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as osteoarthritis, rheumatoid arthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, or complications from a previous prosthesis. The Balanced Knee System (BKS) will be used to treat patients undergoing a total knee replacement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Loss of joint configuration and joint function.
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint.
- Post-traumatic arthritis of the knee joint.
- Moderate valgus, varus, or flexion deformities.
Key exclusion criteria (11 listed)
- Any patient not experiencing a compromised quality of life by loss of joint function and/or joint configuration, or pain from arthritis disease.
- Any patient whose knee cannot be returned to normal function and normal stability through reconstructive procedures, including ligamentous balancing.
- Active infection in or near the knee joint, fever and/or local inflammation signs, and elevation of sedimentation rate unexplained by other diseases should not be treated unless preoperative infection is ruled out.
- Distant foci of infection, such as genitourinary, pulmonary, skin (chronic lesions or ulcerations), and other sites, which may result in hematogenous spread to the implant site.
- Rapid joint destruction or bone absorption apparent on roentgenograms.
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 |
|---|---|---|
| Balanced Knee SystemAlso: BKSA multi-compartmental total knee replacement providing a system of components for primary posterior cruciate ligament substituting procedures. The system consists of femoral, tibial, and patellar components that allow the surgeon to select the most appropriate component combination to meet specific patient needs. | Device | Total Knee Replacement |
Primary outcome
Evaluate effectiveness of the BKS by assessing complications during surgery and the post-operative follow-up period
Time frame: 1-10 years
3 secondary outcomes
Assess the effectiveness of the BKS by analyzing radiographic evidence and clinical data.
Time frame: 1-10 years
Identify any surveillance issues regarding the device design and surgical approach used refinement of the surgical technique
Time frame: 1-10 years
Evaluate device performance through the use of the Knee Society Score, Short Form-36 Health Survey, and radiographic evaluation.
Time frame: 1-10 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 24 Sep 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.
Michael H. Bourne, M.D. principal investigator
Salt Lake Orthopaedic Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Balanced Knee System in people with Osteoarthritis, Knee and Rheumatoid Arthritis of Knee, run by Ortho Development Corporation.
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 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 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate effectiveness of the BKS by assessing complications during surgery and the post-operative follow-up period (time frame: 1-10 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 24 Sep 2021.