Total Knee ReplacementNCT01777009
The Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty
A study testing Primary Total Knee Replacement Surgery in people with Total Knee Replacement and Arthroplasty, run by Northwell Health at 1 site in United States.
Trial summary
Short and long term outcomes of total knee arthroplasty patients surgically exposed with patellar eversion are compared to those patients exposed by laterally retracting the patella. It was hypothesized that there would be no difference. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement, Arthroplasty, Patella
- What is being tested?
- Primary Total Knee Replacement Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Apr 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for study participation included all comers for primary total knee arthroplasty indicated for degenerative joint disease. All operations were performed by three well-established arthroplasty-fellowship-trained orthopaedic surgeons using surgical techniques based on that of a senior surgeon. All implanted devices were cruciate-substituting tricompartmental total knee replacements placed through a medial parapatellar approach. All patients were anaesthetized with spinal anesthesia, received a peri-operative cocktail injection, and had tourniquet times between 0 and 120 minutes. Multi-modal post-operative pain management and accelerated physical therapy were performed as previously described.
Who cannot join
- Patients were excluded from the study if on the operative side they had undergone prior total knee replacement, prior knee arthrotomy, prior osteotomy at or about the knee, or had preoperative angular deformity greater than 20 degrees.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Prospective Study Evaluating the Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty.
Short and long term outcomes of total knee arthroplasty patients surgically exposed with patellar eversion are compared to those patients exposed by laterally retracting the patella. It was hypothesized that there would be no difference.
Read the detailed description
Background:
Patellar mobilization during total knee arthroplasty (TKA) has been debated, with some proponents of minimally invasive TKA suggesting that laterally retracting, rather than everting the patella may be beneficial. It was our hypothesis that by using randomized, prospective, blinded study methods, there would be no significant difference in clinical outcome measures based solely on eversion of the patella during total knee arthroplasty.
Methods:
After an a priori power analysis was done, 120 primary total knee replacements indicated for degenerative joint disease were included in the study and randomized to one of two patella exposure techniques: lateral retraction or eversion. Collaborating investigators and patients were blinded to randomization.
- Conditions
- Total Knee Replacement, Arthroplasty, Patella
- Being tested
- Primary Total Knee Replacement Surgery
- Keywords
- Total Knee Replacement, Patellar Eversion, Surgical Exposure, Outcomes, Quadriceps Strength, Straight Leg Raise, SF-36
- Medical subject headings
- Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Total Knee Replacement SurgeryProcedure or surgery
Patients randomized to the eversion group had patellas everted during the flexion portions of the surgery. Patients randomized to the retraction group had patellas everted only for the patellar resurfacing portions of the surgery. Both groups were mobilized with anterior tibial translation. All other aspects of surgery including postoperative care, anticoagulation, pain control, and physical therapy were done as per standard arthroplasty protocols at our institution.
| Study group | Role | What they receive |
|---|---|---|
| Patellar Eversion | Experimental | Patients randomized to the Patellar Eversion arm of the study were surgically exposed by everting the patella during their Primary Total Knee Replacement Surgery. Receives: Procedure: Primary Total Knee Replacement Surgery |
| Patellar Lateral Retraction | Active comparator | Patients randomized to the Patellar Lateral Retraction arm of the study were surgically exposed by laterally retracting the patella during their Primary Total Knee Replacement Surgery. Receives: Procedure: Primary Total Knee Replacement Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in quadriceps strength
Quadriceps strength was measured isometrically using a Biodex dynamometer with the patient's knee in 60 degrees of flexion.
Measured: preop, 6 weeks, 3 months, 1 year postop
Secondary outcomes (6)
change in ability to perform straight leg raise
For the purposes of this study, we defined the ability to straight leg raise as a patient independently raising their heel 6 inches off of the bed with foot dorsiflexed and knee fully extended without extension lag.
Measured: up to three days postop
change in Visual Analog Scale of Pain
Patient reported pain using standardized VAS diagram
Measured: preop, up to 3 days postop, 6 weeks, 3 months, and 1 year postop
change in Ambulation Distance
Measured: up to 3 days postop
Length of Hospital Stay
Measured: expected average 2 to 3 days
change in SF-36 score
Measured: preop, 6 weeks, 3 months, 1 year postop
change in Range of knee motion
goniometer used to standardize measurements
Measured: preop, 6 weeks, 3months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startMar 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose A Rodriguez, MD, Principal investigator, Lenox Hill HospitalDerek R Jenkins, MD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777009
- Sponsor's protocol ID
- Patellar Mobilization
- Status last verified
- Jan 2013
- First submitted
- 22 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Prospective Study Evaluating the Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT01777009
- Acronym / sponsor ID
- Patellar Mobilization
- Conditions
- Total Knee Replacement, Arthroplasty, Patella
- Keywords
- Total Knee Replacement, Patellar Eversion, Surgical Exposure, Outcomes, Quadriceps Strength, Straight Leg Raise, SF-36
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Jan 2013 (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.
Short and long term outcomes of total knee arthroplasty patients surgically exposed with patellar eversion are compared to those patients exposed by laterally retracting the patella. It was hypothesized that there would be no difference.
Detailed description
Background:
Patellar mobilization during total knee arthroplasty (TKA) has been debated, with some proponents of minimally invasive TKA suggesting that laterally retracting, rather than everting the patella may be beneficial. It was our hypothesis that by using randomized, prospective, blinded study methods, there would be no significant difference in clinical outcome measures based solely on eversion of the patella during total knee arthroplasty.
Methods:
After an a priori power analysis was done, 120 primary total knee replacements indicated for degenerative joint disease were included in the study and randomized to one of two patella exposure techniques: lateral retraction or eversion. Collaborating investigators and patients were blinded to randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patellar Eversion | Experimental | Procedure: Primary Total Knee Replacement SurgeryPatients randomized to the Patellar Eversion arm of the study were surgically exposed by everting the patella during their Primary Total Knee Replacement Surgery. |
| Patellar Lateral Retraction | Active comparator | Procedure: Primary Total Knee Replacement SurgeryPatients randomized to the Patellar Lateral Retraction arm of the study were surgically exposed by laterally retracting the patella during their Primary Total Knee Replacement Surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for study participation included all comers for primary total knee arthroplasty indicated for degenerative joint disease. All operations were performed by three well-established arthroplasty-fellowship-trained orthopaedic surgeons using surgical techniques based on that of a senior surgeon. All implanted devices were cruciate-substituting tricompartmental total knee replacements placed through a medial parapatellar approach. All patients were anaesthetized with spinal anesthesia, received a peri-operative cocktail injection, and had tourniquet times between 0 and 120 minutes. Multi-modal post-operative pain management and accelerated physical therapy were performed as previously described.
Key exclusion criteria (1 listed)
- Patients were excluded from the study if on the operative side they had undergone prior total knee replacement, prior knee arthrotomy, prior osteotomy at or about the knee, or had preoperative angular deformity greater than 20 degrees.
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 |
|---|---|---|
| Primary Total Knee Replacement SurgeryPatients randomized to the eversion group had patellas everted during the flexion portions of the surgery. Patients randomized to the retraction group had patellas everted only for the patellar resurfacing portions of the surgery. Both groups were mobilized with anterior tibial translation. All other aspects of surgery including postoperative care, anticoagulation, pain control, and physical therapy were done as per standard arthroplasty protocols at our institution. | Procedure or surgery | Patellar Eversion, Patellar Lateral Retraction |
Primary outcome
change in quadriceps strength
Time frame: preop, 6 weeks, 3 months, 1 year postop
Quadriceps strength was measured isometrically using a Biodex dynamometer with the patient's knee in 60 degrees of flexion.
6 secondary outcomes
change in ability to perform straight leg raise
Time frame: up to three days postop
change in Visual Analog Scale of Pain
Time frame: preop, up to 3 days postop, 6 weeks, 3 months, and 1 year postop
change in Ambulation Distance
Time frame: up to 3 days postop
Length of Hospital Stay
Time frame: expected average 2 to 3 days
change in SF-36 score
Time frame: preop, 6 weeks, 3 months, 1 year postop
change in Range of knee motion
Time frame: preop, 6 weeks, 3months, 1 year
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 28 Jan 2013.
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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.
Jose A Rodriguez, MD principal investigator
Lenox Hill Hospital
Derek R Jenkins, MD study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Total Knee Replacement Surgery in people with Total Knee Replacement and Arthroplasty, run by Northwell Health 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 1 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 28 Jan 2013. 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?
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?
change in quadriceps strength (time frame: preop, 6 weeks, 3 months, 1 year postop). 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 28 Jan 2013.