Knee Replacement SurgeryPhase 4NCT01375231
Anatomic Reconstruction of the Patellofemoral Joint
A Phase 4 study testing Measured Resection of patellofemoral joint and Measured resection of patella in people with Knee Replacement Surgery, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
The investigators posit that it would be advantageous to reproduce the height of the entire patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Replacement Surgery
- What is being tested?
- Measured Resection of patellofemoral joint and Measured resection of patella
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to May 2013
- Phase
- Phase 4
- 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
- Patients presenting for a primary total knee replacement who have failed conservative medical management.
- Total knee replacement includes patella resurfacing.
- Patient is willing and able to understand, sign, and date the study specific patient informed consent, to volunteer participation in the study.
- Patient is psychosocially, mentally, and physically able to comply with the requirements of the study including post-op clinical evaluations and completion of questionnaires.
Who cannot join
- Patients presenting for a unicompartmental knee replacement.
- Patients presenting for a revision total knee replacement.
- Total knee replacement does not include patella resurfacing.
- Patients with angular deformity greater than 15 degrees.
- Patients with subluxation/dislocation of the patella.
- Patients with severe patellar bone loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoCarolina Research Institute/OrthoCarolina
Charlotte, North Carolina, 28207
About this study
Official title: Anatomic Reconstruction of the Patellofemoral Joint: A Solution for Anterior Knee Pain
The investigators posit that it would be advantageous to reproduce the height of the entire patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient. For example the quadriceps mechanism would have to work harder if the total patellofemoral (PF) height is diminished. Alternatively, diminished motion or increased patellar strain may occur if the overall PF height is increased. The investigators theorize that either of these sizing errors could lead to anterior knee pain. The purpose of this study is to compare the clinical outcomes between two surgical techniques: 1) a technique of reproducing the total PF joint on both sides of the articulation (Group 1) and 2) the traditional technique of reproducing only the patellar thickness on one side of the joint (Group 2).
Read the detailed description
There is no consensus on the source of the anterior pain or the most efficacious treatment. Multiple etiologies have been theorized concerning the cause of this problem including tibiofemoral instability, patellofemoral (PF) instability, PF maltracking and patella stress fractures. It has been reported that patellofemoral forces are associated with anterior knee pain. Moreover, it has been reported that a correlation exists between the tension of the quadriceps muscle and the forces on the patella. In a biomechanical, cadaver study, Browne et al. found that a longer extensor moment arm reduced the tension on the quadriceps and reduced the patellar forces.
- Conditions
- Knee Replacement Surgery
- Being tested
- Measured Resection of patellofemoral joint, Measured resection of patella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measured Resection of patellofemoral jointProcedure or surgery
The goal is to remove an amount of bone from the patella so that when reconstructed, the composite thickness of the entire prosthetic patellofemoral joint is recreated
Measured resection of patellaProcedure or surgery
The thickness of the anterior condyle is not considered in this measurement. The goal is to restore the composite thickness of the patella only.
| Study group | Role | What they receive |
|---|---|---|
| Measured Resection of patellofemoral joint | Active comparator | The goal is to remove an amount of bone from the patella so that when reconstructed, the composite thickness of the entire prosthetic patellofemoral joint is recreated Receives: Procedure: Measured Resection of patellofemoral joint |
| Measured resection of patella | Active comparator | The thickness of the anterior condyle is not considered in this measurement. The goal is to restore the composite thickness of the patella only. Receives: Procedure: Measured resection of patella |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior knee Pain
Measured by visual analog scale
Measured: 1 year postoperatively
Secondary outcomes (2)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measure patient reported pain, symptoms, activity of daily living, sport and recreation function and knee related quality of life
Measured: 1 year postoperative
Range of Motion of knee
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Replacement SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Fehring, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375231
- Sponsor's protocol ID
- 10019
- Status last verified
- Jun 2014
- First submitted
- 15 Jun 2011
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic Reconstruction of the Patellofemoral Joint: A Solution for Anterior Knee Pain
- ClinicalTrials.gov ID
- NCT01375231
- Acronym / sponsor ID
- 10019
- Conditions
- Knee Replacement Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 Jun 2011 (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 investigators posit that it would be advantageous to reproduce the height of the entire patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient. For example the quadriceps mechanism would have to work harder if the total patellofemoral (PF) height is diminished. Alternatively, diminished motion or increased patellar strain may occur if the overall PF height is increased. The investigators theorize that either of these sizing errors could lead to anterior knee pain. The purpose of this study is to compare the clinical outcomes between two surgical techniques: 1) a technique of reproducing the total PF joint on both sides of the articulation (Group 1) and 2) the traditional technique of reproducing only the patellar thickness on one side of the joint (Group 2).
Detailed description
There is no consensus on the source of the anterior pain or the most efficacious treatment. Multiple etiologies have been theorized concerning the cause of this problem including tibiofemoral instability, patellofemoral (PF) instability, PF maltracking and patella stress fractures. It has been reported that patellofemoral forces are associated with anterior knee pain. Moreover, it has been reported that a correlation exists between the tension of the quadriceps muscle and the forces on the patella. In a biomechanical, cadaver study, Browne et al. found that a longer extensor moment arm reduced the tension on the quadriceps and reduced the patellar forces.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measured Resection of patellofemoral joint | Active comparator | Procedure: Measured Resection of patellofemoral jointThe goal is to remove an amount of bone from the patella so that when reconstructed, the composite thickness of the entire prosthetic patellofemoral joint is recreated |
| Measured resection of patella | Active comparator | Procedure: Measured resection of patellaThe thickness of the anterior condyle is not considered in this measurement. The goal is to restore the composite thickness of the patella only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presenting for a primary total knee replacement who have failed conservative medical management.
- Total knee replacement includes patella resurfacing.
- Patient is willing and able to understand, sign, and date the study specific patient informed consent, to volunteer participation in the study.
- Patient is psychosocially, mentally, and physically able to comply with the requirements of the study including post-op clinical evaluations and completion of questionnaires.
Key exclusion criteria (6 listed)
- Patients presenting for a unicompartmental knee replacement.
- Patients presenting for a revision total knee replacement.
- Total knee replacement does not include patella resurfacing.
- Patients with angular deformity greater than 15 degrees.
- Patients with subluxation/dislocation of the patella.
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 |
|---|---|---|
| Measured Resection of patellofemoral jointThe goal is to remove an amount of bone from the patella so that when reconstructed, the composite thickness of the entire prosthetic patellofemoral joint is recreated | Procedure or surgery | Measured Resection of patellofemoral joint |
| Measured resection of patellaThe thickness of the anterior condyle is not considered in this measurement. The goal is to restore the composite thickness of the patella only. | Procedure or surgery | Measured resection of patella |
Primary outcome
Anterior knee Pain
Time frame: 1 year postoperatively
Measured by visual analog scale
2 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1 year postoperative
Range of Motion of knee
Time frame: 1 year postoperative
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 30 Jun 2014.
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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.
Thomas Fehring, MD principal investigator
OrthoCarolina Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Measured Resection of patellofemoral joint and Measured resection of patella in people with Knee Replacement Surgery, run by OrthoCarolina Research Institute, Inc. 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 6 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 30 Jun 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anterior knee Pain (time frame: 1 year postoperatively). 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 30 Jun 2014.