Osteoarthritis, KneeNCT04419311
Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties
A study testing Vanguard® Knee System in people with Osteoarthritis, Knee and Knee Arthritis, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The choice between ultra-congruent (UC) insert or posterior cruciate ligament-stabilized (PS) insert in posterior cruciate ligament (PCL) sacrificing total knee arthroplasty (TKA) remains debatable. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Knee Arthritis
- What is being tested?
- Vanguard® Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2017to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 55 and 80 years
- Scheduled to undergo unilateral TKA on for primary knee osteoarthritis
Who cannot join
- Rheumatological joint diseases
- Previous knee surgery
- Neuromuscular diseases
- Bilateral TKA
- Insufficiency of collateral ligaments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aksaray University Training and Research Hospital
Aksaray, 68200
About this study
Official title: Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties: A Randomized Controlled Trial
The choice between ultra-congruent (UC) insert or posterior cruciate ligament-stabilized (PS) insert in posterior cruciate ligament (PCL) sacrificing total knee arthroplasty (TKA) remains debatable. Despite the potential advantages of the UC insert over PS insert with its different design, there are concerns about inferior clinical outcome related to its use. Therefore, isokinetic performance was used in this study to objectively evaluate knee function after TKA and the clinical scores of the patients were also evaluated. To the best of our knowledge, no prospective randomized study has compared the isokinetic performance of the knee following the use of UC and PS inserts in TKA. The hypothesis of the present study was that compared with the PS insert, the UC insert would be associated with a lower clinical outcome and isokinetic performance following TKA.
A total of 65 patients scheduled to undergo TKA on for primary knee osteoarthritis were randomly assigned to either the UC (32 patients) or the PS group (33 patients). The Knee Society Score (KSS) and isokinetic performance results of each patient were recorded preoperatively and at postoperative 3, 6 and 12 months. The physiatrist performing isokinetic tests and patients were blinded to the study.
Read the detailed description
Eligibility of all patients between 55 and 80 years, scheduled to undergo unilateral TKA on for primary knee osteoarthritis will be evaluated. The exclusion criteria are rheumatological joint diseases, previous knee surgery, neuromuscular diseases, bilateral TKA, or insufficiency of collateral ligaments. Patients will be randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the UC insert or PS insert group before the operation. Unblinded senior resident will implement the randomization. Patients and physiatrists performing isokinetic measurements will be blinded to group allocation.
During the UC and PS operations, Vanguard® Complete Knee System prosthesis (Zimmer Biomet Inc., Warsaw, IN, USA) will be implanted using the same surgical technique in all patients. The Vanguard anterior-stabilized (AS) insert is a UC deep-dish design with a 10 mm prominent anterior lip and 5mm posterior lip. This bone-conserving design prevents anterior femoral subluxation because of the prominent anterior lip. The insert design allows it to be used with the Vanguard cruciate-retaining femoral component and the highly congruent articulating surface increases rotational stability. There is more contact area between the femoral component and the weight-bearing surface to decrease the shear stress between the femur and polyethylene insert.
A tourniquet will be inflated to pressure of 300 mmHg after spinal anesthesia. All operations will be performed with the same surgical technique by a single senior surgeon. Patellar surface arthroplasty will be performed in all the cases. Both femoral and tibial prostheses will be implanted with pressured bone cement. A suction drain will be placed inside the knee capsule. On the morning of the first day after surgery patients will be mobilized under the supervision of the physical therapist. All patients will undergo the same rehabilitation procedure during the outpatient period and will be examined by the same physiatrist at the regular 3, 6, and 12-month follow-up visits.
The primary outcome is isokinetic performance, measured as peak knee extensor and flexor torque values in Newton-meters, on the operated knee. Measurements wilil be done preoperatively and at 3, 6, and 12-month follow-up examinations under the supervision of the same physiatrist. At same time points, the Knee Society Score (KSS) will be evaluated as well. Isokinetic measurements will be performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc., Shirley, NY, USA) by the same senior physiatrist. Patients will be positioned on the dynamometer with the hip in 90° in a sitting position for the knee flexion and extension measurements. Lateral movement of the knee will be prevented during full extension and flexion of the knee by a thigh strap on the operated leg. The physical therapist will help the patients to achieve proper positioning before each test. Concentric isokinetic knee flexion-extensions will be assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions will be completed by each patient. Instructions will be provided, and one trial repetition will then performed by all patients before the measurements were taken.
Sample size estimation will be performed using the extension peak torque as a primary effect variable. As there is no similar study with isokinetic measurements regarding this subject, a difference in mean values of 10 Nm and standard deviation of 12 Nm were assumed for each group. The group sample sizes of 31 and 31 achieved a power of 0.90 to detect a difference of 10 Nm between the two groups with estimated group standard deviations of 12 for each group and with a significance level (alpha) of 0.05 using a two-sided, two-sample test. Considering the loss to follow-up, two patients were added to each group. Thus, recruitment will end after 33 patients were assigned to either groups. All data will be calculated as mean and standard deviation. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed with SPSS 22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp.). A value of p< 0.05 will be considered statistically significant.
- Conditions
- Osteoarthritis, Knee, Knee Arthritis
- Being tested
- Vanguard® Knee System
- Keywords
- Ultra-congruent insert, Posterior cruciate ligament-stabilized insert, Isokinetic test, Strength, Total 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.
Vanguard® Knee SystemDevice
Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-congruent insert group | Experimental | Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group. Receives: Device: Vanguard® Knee System |
| Posterior cruciate ligament-stabilized insert | Experimental | Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group. Receives: Device: Vanguard® Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Assessment of Peak Knee Extensor Torque Preoperatively
Peak extensor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Measured: Preoperative
Baseline Assessment of Peak Knee Flexor Torque Preoperatively
Peak flexor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Measured: Preoperative
Assessment of Peak Knee Extensor Torque at 3 Months Postoperatively
Peak extensor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Measured: 3 months postoperative
Assessment of Peak Knee Flexor Torque at 3 Months Postoperatively
Peak flexor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Measured: 3 months postoperative
Assessment of Peak Knee Extensor Torque at 6 Months Postoperatively
Peak extensor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Measured: 6 months postoperative
Assessment of Peak Knee Flexor Torque at 6 Months Postoperatively
Peak flexor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Measured: 6 months postoperative
Assessment of Peak Knee Extensor Torque at 12 Months Postoperatively
Peak extensor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Measured: 12 months postoperative
Assessment of Peak Knee Flexor Torque at 12 Months Postoperatively
Peak flexor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Measured: 12 months postoperative
Secondary outcomes (8)
Baseline Knee Society Clinical Score Evaluation
The Knee Society Score were applied preoperatively.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
Measured: Preoperative
Knee Society Clinical Score Evaluation at 3 Months Postoperatively
The Knee Society Clinical Score were applied at postoperative 3 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
Measured: 3 months postoperative
Knee Society Clinical Score Evaluation at 6 Months Postoperatively
The Knee Society Clinical Score were applied at postoperative 6 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
Measured: 6 months postoperative
Knee Society Clinical Score Evaluation at 12 Months Postoperatively
The Knee Society Clinical Score were applied at postoperative 12 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
Measured: 12 months postoperative
Baseline Knee Society Functional Score Evaluation
The Knee Society Functional Score were applied preoperatively.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
Measured: Preoperative
Knee Society Functional Score Evaluation at 3 Months Postoperatively
The Knee Society Functional Score were applied at postoperative 3 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
Measured: 3 months postoperative
Knee Society Functional Score Evaluation at 6 Months Postoperatively
The Knee Society Functional Score were applied at postoperative 6 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
Measured: 6 months postoperative
Knee Society Functional Score Evaluation at 12 Months Postoperatively
The Knee Society Functional Score were applied at postoperative 12 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start19 Jan 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the UC insert or PS insert group before the TKA operation (Figure 1). Unblinded senior resident implemented the randomization. Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdem A Sezgin, Aksaray University Training and Research Hospital
- Investigators
- Deniz Çankaya, MD, Principal investigator, Aksaray University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419311
- Sponsor's protocol ID
- 1585/2017
- Status last verified
- Feb 2021
- First submitted
- 1 Jun 2020
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04419311
- Acronym / sponsor ID
- 1585/2017
- Conditions
- Osteoarthritis, Knee, Knee Arthritis
- Keywords
- Ultra-congruent insert, Posterior cruciate ligament-stabilized insert, Isokinetic test, Strength, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The choice between ultra-congruent (UC) insert or posterior cruciate ligament-stabilized (PS) insert in posterior cruciate ligament (PCL) sacrificing total knee arthroplasty (TKA) remains debatable. Despite the potential advantages of the UC insert over PS insert with its different design, there are concerns about inferior clinical outcome related to its use. Therefore, isokinetic performance was used in this study to objectively evaluate knee function after TKA and the clinical scores of the patients were also evaluated. To the best of our knowledge, no prospective randomized study has compared the isokinetic performance of the knee following the use of UC and PS inserts in TKA. The hypothesis of the present study was that compared with the PS insert, the UC insert would be associated with a lower clinical outcome and isokinetic performance following TKA.
A total of 65 patients scheduled to undergo TKA on for primary knee osteoarthritis were randomly assigned to either the UC (32 patients) or the PS group (33 patients). The Knee Society Score (KSS) and isokinetic performance results of each patient were recorded preoperatively and at postoperative 3, 6 and 12 months. The physiatrist performing isokinetic tests and patients were blinded to the study.
Detailed description
Eligibility of all patients between 55 and 80 years, scheduled to undergo unilateral TKA on for primary knee osteoarthritis will be evaluated. The exclusion criteria are rheumatological joint diseases, previous knee surgery, neuromuscular diseases, bilateral TKA, or insufficiency of collateral ligaments. Patients will be randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the UC insert or PS insert group before the operation. Unblinded senior resident will implement the randomization. Patients and physiatrists performing isokinetic measurements will be blinded to group allocation.
During the UC and PS operations, Vanguard® Complete Knee System prosthesis (Zimmer Biomet Inc., Warsaw, IN, USA) will be implanted using the same surgical technique in all patients. The Vanguard anterior-stabilized (AS) insert is a UC deep-dish design with a 10 mm prominent anterior lip and 5mm posterior lip. This bone-conserving design prevents anterior femoral subluxation because of the prominent anterior lip. The insert design allows it to be used with the Vanguard cruciate-retaining femoral component and the highly congruent articulating surface increases rotational stability. There is more contact area between the femoral component and the weight-bearing surface to decrease the shear stress between the femur and polyethylene insert.
A tourniquet will be inflated to pressure of 300 mmHg after spinal anesthesia. All operations will be performed with the same surgical technique by a single senior surgeon. Patellar surface arthroplasty will be performed in all the cases. Both femoral and tibial prostheses will be implanted with pressured bone cement. A suction drain will be placed inside the knee capsule. On the morning of the first day after surgery patients will be mobilized under the supervision of the physical therapist. All patients will undergo the same rehabilitation procedure during the outpatient period and will be examined by the same physiatrist at the regular 3, 6, and 12-month follow-up visits.
The primary outcome is isokinetic performance, measured as peak knee extensor and flexor torque values in Newton-meters, on the operated knee. Measurements wilil be done preoperatively and at 3, 6, and 12-month follow-up examinations under the supervision of the same physiatrist. At same time points, the Knee Society Score (KSS) will be evaluated as well. Isokinetic measurements will be performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc., Shirley, NY, USA) by the same senior physiatrist. Patients will be positioned on the dynamometer with the hip in 90° in a sitting position for the knee flexion and extension measurements. Lateral movement of the knee will be prevented during full extension and flexion of the knee by a thigh strap on the operated leg. The physical therapist will help the patients to achieve proper positioning before each test. Concentric isokinetic knee flexion-extensions will be assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions will be completed by each patient. Instructions will be provided, and one trial repetition will then performed by all patients before the measurements were taken.
Sample size estimation will be performed using the extension peak torque as a primary effect variable. As there is no similar study with isokinetic measurements regarding this subject, a difference in mean values of 10 Nm and standard deviation of 12 Nm were assumed for each group. The group sample sizes of 31 and 31 achieved a power of 0.90 to detect a difference of 10 Nm between the two groups with estimated group standard deviations of 12 for each group and with a significance level (alpha) of 0.05 using a two-sided, two-sample test. Considering the loss to follow-up, two patients were added to each group. Thus, recruitment will end after 33 patients were assigned to either groups. All data will be calculated as mean and standard deviation. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed with SPSS 22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp.). A value of p< 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients were randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the UC insert or PS insert group before the TKA operation (Figure 1). Unblinded senior resident implemented the randomization. Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Ultra-congruent insert group | Experimental | Device: Vanguard® Knee SystemUltra-congruent inserts were used during total knee arthroplasty in patients randomized to this group. |
| Posterior cruciate ligament-stabilized insert | Experimental | Device: Vanguard® Knee SystemPosterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 55 and 80 years
- Scheduled to undergo unilateral TKA on for primary knee osteoarthritis
Key exclusion criteria (5 listed)
- Rheumatological joint diseases
- Previous knee surgery
- Neuromuscular diseases
- Bilateral TKA
- Insufficiency of collateral ligaments
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 |
|---|---|---|
| Vanguard® Knee SystemPosterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert. | Device | Posterior cruciate ligament-stabilized insert, Ultra-congruent insert group |
Primary outcome
Baseline Assessment of Peak Knee Extensor Torque Preoperatively
Time frame: Preoperative
Peak extensor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Baseline Assessment of Peak Knee Flexor Torque Preoperatively
Time frame: Preoperative
Peak flexor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Assessment of Peak Knee Extensor Torque at 3 Months Postoperatively
Time frame: 3 months postoperative
Peak extensor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Assessment of Peak Knee Flexor Torque at 3 Months Postoperatively
Time frame: 3 months postoperative
Peak flexor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Assessment of Peak Knee Extensor Torque at 6 Months Postoperatively
Time frame: 6 months postoperative
Peak extensor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Assessment of Peak Knee Flexor Torque at 6 Months Postoperatively
Time frame: 6 months postoperative
Peak flexor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Assessment of Peak Knee Extensor Torque at 12 Months Postoperatively
Time frame: 12 months postoperative
Peak extensor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Assessment of Peak Knee Flexor Torque at 12 Months Postoperatively
Time frame: 12 months postoperative
Peak flexor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
8 secondary outcomes
Baseline Knee Society Clinical Score Evaluation
Time frame: Preoperative
Knee Society Clinical Score Evaluation at 3 Months Postoperatively
Time frame: 3 months postoperative
Knee Society Clinical Score Evaluation at 6 Months Postoperatively
Time frame: 6 months postoperative
Knee Society Clinical Score Evaluation at 12 Months Postoperatively
Time frame: 12 months postoperative
Baseline Knee Society Functional Score Evaluation
Time frame: Preoperative
Knee Society Functional Score Evaluation at 3 Months Postoperatively
Time frame: 3 months postoperative
Knee Society Functional Score Evaluation at 6 Months Postoperatively
Time frame: 6 months postoperative
Knee Society Functional Score Evaluation at 12 Months Postoperatively
Time frame: 12 months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Deniz Çankaya, MD principal investigator
Aksaray University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vanguard® Knee System in people with Osteoarthritis, Knee and Knee Arthritis, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 16 Mar 2021. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Baseline Assessment of Peak Knee Extensor Torque Preoperatively (time frame: Preoperative). The study lists 8 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 16 Mar 2021.