OsteoarthritisPhase 4NCT01418378
Sigma CR150 Versus Sigma CR Knee RCT
A Phase 4 study testing Sigma CR150 and Sigma CR in people with Osteoarthritis, run by DePuy International at 4 sites in 3 countries.
Trial summary
This study will compare two very similar designs of knee replacement device. One device (Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been modified to enhance/accommodate higher flexion. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Sigma CR150 and Sigma CR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 3 Aug 2011to 17 Feb 2016
- Phase
- Phase 4
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- i)Male or female subjects, aged between 50 and 75 years inclusive.
- ii)Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects defined by the Investigator as ASA Grade I or II.
- Subjects with a primary diagnosis of osteoarthritis.
- Subjects who require a primary total knee arthroplasty.
- Subjects who can achieve active flexion of 90 degrees.
Who cannot join
- Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical investigation with an investigational product in the last month.
- Subjects who are currently involved in any injury litigation claims.
- Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
- Subjects with a fixed flexion deformity of over 20 degrees.
Show all 19Show fewer
- Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
- Subjects who cannot flex their hip to 90 degrees.
- Subjects with a BMI of 35 or above.
- Subjects defined by the Investigator as ASA Grade III-V.
- Subjects who are identified pre-operatively as having bone defects which require augmentation.
- Subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, ORIF or with previous fracture in the knee joint.
- Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.
- Subjects who have undergone contralateral total knee arthroplasty during the previous 6 months.
- Subjects who in the opinion of the Investigator require patellar resurfacing.
- Intra-operative exclusion criteria:
- Subjects who have uncontained bone defects or defects bigger than 8 mm3 and/or require augmentation.
- Subjects who are not suitable to receive both the study and comparator devices.
- Subjects who require patellar resurfacing
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Calderdale Royal Hospital
Halifax, West Yorkshire, HX3 0PW
Victoria Hospital
Kirkcaldy, Fife, KY2 5AH
About this study
Official title: A Double-blinded Randomised Controlled Trial Comparing the Performance of the Sigma® CR150 and Sigma® CR Knee Systems, When Used in Fixed Bearing Primary Cruciate Retaining Total Knee Arthroplasty for the Treatment of Osteoarthritis
This study will compare two very similar designs of knee replacement device. One device (Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been modified to enhance/accommodate higher flexion. The original device has been in widespread clinical use with excellent results since 1996 and this study will determine whether the design modifications of the newer device add further value. The newer device has been in clinical use with good short-term(unpublished) outcomes since becoming commercially available in January 2009.
Achieving higher knee flexion may be required for cultural reasons or by the increasingly younger, more active patient population undergoing knee replacement today. In addition to promoting flexion, it is also possible that this design change may help the knee replacement to last longer than traditional implants in patients who achieve higher flexion. Therefore, the study will compare the two devices in terms of survivorship, flexion and other measures of the success of a total knee replacement (range of motion, knee-related quality of life, activity and generic quality of life) over the short-term.
Read more
A minimum of one hundred and forty subjects (minimum 70 per group) with osteoarthritis and aged 50-75 years will be included at UK/international hospitals.
Study duration is 2 years and patients will complete standard knee outcome scores plus radiological evaluation.
Subjects would receive one of the study devices regardless of their involvement in the study, and apart from (possible)additional visits, x-rays and/or questionnaires, treatment and follow-up care will be as per the care they would receive outside of the study.
- Conditions
- Osteoarthritis
- Being tested
- Sigma CR150, Sigma CR
- Keywords
- Sigma, cruciate, retaining, fixed, primary, total, knee, arthroplasty, cemented, osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigma CR150Device
Also called PFC Sigma CR150
Sigma CR150 femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).
Sigma CRDevice
Also called PFC Sigma CR
Sigma CR femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).
| Study group | Role | What they receive |
|---|---|---|
| Sigma CR150 | Active comparator | Sigma CR150 femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing). Receives: Device: Sigma CR150 |
| Sigma CR | Active comparator | Sigma CR femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing). Receives: Device: Sigma CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Knees Who Survived at 2 Years Post-operative
The Kaplan-Meier success rate at 24-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no components revised for any reason) was censored at the time of last follow-up.
Measured: 2 Years
Secondary outcomes (33)
Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years
Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg
Measured: Pre-operative baseline to 2 years
Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year
Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Pain Subscore
The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale.
100 - (score x 100) / 36 = transformed score
Measured: Pre-operative baseline to 1 year
Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Pain Subscore
The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale.
100 - (score x 100) / 36 = transformed score
Measured: 2 years
Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years
Comparative evaluation of the change from baseline values at 1 year in Knee Injury and Osteoarthritis Outcome Symptom Subscore
The subscore ranges from 0 (no symptoms) to 36 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale.
100 - (score x 100) / 36 = transformed score
Measured: 1 years
Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore
The subscore ranges from 0 (never have symptoms) to 28 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale.
100 - (score x 100) / 28 = transformed score
Measured: 2 years
Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 1 Years
Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore
The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.
100 - (score x 100) / 68 = transformed score
Measured: 1 year
Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore
The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.
100 - (score x 100) / 68 = transformed score
Measured: 2 year
Knee Injury and Osteoarthritis Outcome - Sport and Recreation Subscore - 1 Years
Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore
The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.
100 - (score x 100) / 20 = transformed score
Measured: 1 year
Knee Injury and Osteoarthritis Outcome Sport and Recreation Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore
The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.
100 - (score x 100) / 20 = transformed score
Measured: 2 year
Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 1 Years
Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Quality of life Subscore
The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.
100 - (score x 100) / 16 = transformed score
Measured: 1 year
Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Quality of Life Subscore
The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.
100 - (score x 100) / 16 = transformed score
Measured: 2 years
Change From Baseline in Goniometer Measured Maximum Passive Flexion at 1 Year.
Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive Flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive flexion involves moving the leg through range of motion without active muscle contraction
Measured: 1 year
Change From Baseline in Goniometer Measured Maximum Passive Extension at 1 Year
Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves the leg being moved without active muscle contraction
Measured: 1 year
Change From Baseline in Goniometer Measured Maximum Passive Extension at 2 Years
Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves moving the leg without active muscle contraction
Measured: 2 year
Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 1 Year
Comparative evaluation of the change from baseline values in 1 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg.
Measured: 1 year
Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 2 Years.
Comparative evaluation of the change from baseline values in 2 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg.
Measured: 2 years
Number of Participants With Flexion Contracture at 1 Year
Summary of flexion contracture at 1 year time point. Flexion contracture is a shortening of the muscles that prevents the leg from fully extending
Measured: 1 years
Number of Participants With Flexion Contracture at 2 Years
Summary of flexion contracture at 2 year time point.Flexion contracture is a shortening of the muscles that prevents the leg from fully extending
Measured: 2 years
Total Knee Society Score at 1 Year
Total Knee Society Knee Score change from baseline at 1 year
The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100
The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60.
Measured: 1 year
Total Knee Society Knee Score at 2 Years
Total Knee Society Knee Score change from baseline at 2 years
The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100
The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60.
Measured: 2 years
Anatomic Alignment Angle
Anatomic angle measured at 1 year time point.
If one draws a line from the center of the hip joint to the center of the ankle joint this is considered to be the mechanical axis of the femur.
A line drawn through the center of the femoral shaft is the anatomic axis.
The angle created at the intersection of these lines is referred to as the anatomic alignment angle.
A normal angle is approximately 7-9 degrees "valgus" or slightly "knock-kneed". "Varus" angles are less common and are also referred to as "bow-legged".
Measured: 1 year time point
Anatomic Alignment Angle
Anatomic angle measured at 2 year time point.
If one draws a line from the center of the hip joint to the center of the ankle joint this is considered to be the mechanical axis of the femur.
A line drawn through the center of the femoral shaft is the anatomic axis.
The angle created at the intersection of these lines is referred to as the anatomic alignment angle.
A normal angle is approximately 7-9 degrees "valgus" or slightly "knock-kneed". "Varus" angles are less common and are also referred to as "bow-legged".
Measured: 2 year time point
Alignment - Femoral Component to Anatomic Angle.
Femoral component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles).
Measured: 1 year time point
Alignment - Femoral Component to Anatomic Angle
Femoral component angle measured at 2 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles).
Measured: 2 year time point
Alignment - Tibial Component to Anatomic Angle
Tibial component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head tibial implant.
Measured: 1 year time point
Alignment - Tibial Component to Anatomic Angle
Tibial component angle measured at 2 year time point. This angle is measured between a line drawn from the center of the femoral head tibial implant.
Measured: 2 year time point
Alignment - Femoral Component Flexion
Femoral Component Flexion measured at 1 year time point. This measures the angle between a line drawn though the center of the side of the femur and a line drawn across the top of the flat inner surface of the femoral component.
Measured: 1 year time point
Alignment - Femoral Component Flexion
Alignment - Femoral Component Flexion measured at 2 year time point. This measures the angle between a line drawn though the center of the side of the femur and a line drawn across the top of the flat inner surface of the femoral component.
Measured: 2 year time point
Alignment - Tibial Posterior Slope
Tibial Posterior Slope measured at 1 year time point. This angle is measured between a line through the center of the side of the tibia and the top flat surface of the tibial implant
Measured: 1 year time point
Alignment - Tibial Posterior Slope
Alignment - Tibial Posterior Slope measured at 2 year time point. This angle is measured between a line through the center of the side of the tibia and the top flat surface of the tibial implant
Measured: 2 year time point
Number of Subjects With Radiolucencies - Femoral Component
The bone-implant interface at the femoral components were examined radiographically and radiolucencies were measured in millimeters.
Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant.
Measured: 6 to 12 week and 24 month intervals
Number of Subjects With Radiolucencies - Tibial Component
The bone-implant interface at the tibial components were examined radiographically and radiolucencies were measured in millimeters.
Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant.
Radiolucent lines greater than 2mm are considered to be clinically significant.
Measured: 6 weeks to 24 months
Radiographic Evaluation of Maximum Flexion
Maximum knee flexion measured radiographically at 1 year time point
Measured: 1 year time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study start3 Aug 2011
- Primary completion17 Feb 2016
- Study completion17 Feb 2016
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 OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gautam Chakrabarty, FRCS Orth., Principal investigator, Calderdale and Huddersfield Foundation NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418378
- Sponsor's protocol ID
- CT07/04
- Status last verified
- Jul 2019
- First submitted
- 9 Aug 2011
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Randomised Controlled Trial Comparing the Performance of the Sigma® CR150 and Sigma® CR Knee Systems, When Used in Fixed Bearing Primary Cruciate Retaining Total Knee Arthroplasty for the Treatment of Osteoarthritis
- ClinicalTrials.gov ID
- NCT01418378
- Acronym / sponsor ID
- CT07/04
- Conditions
- Osteoarthritis
- Keywords
- Sigma, cruciate, retaining, fixed, primary, total, knee, arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2011 (actual)
- Primary completion
- 17 Feb 2016 (actual)
- Study completion
- 17 Feb 2016 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two very similar designs of knee replacement device. One device (Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been modified to enhance/accommodate higher flexion. The original device has been in widespread clinical use with excellent results since 1996 and this study will determine whether the design modifications of the newer device add further value. The newer device has been in clinical use with good short-term(unpublished) outcomes since becoming commercially available in January 2009.
Achieving higher knee flexion may be required for cultural reasons or by the increasingly younger, more active patient population undergoing knee replacement today. In addition to promoting flexion, it is also possible that this design change may help the knee replacement to last longer than traditional implants in patients who achieve higher flexion. Therefore, the study will compare the two devices in terms of survivorship, flexion and other measures of the success of a total knee replacement (range of motion, knee-related quality of life, activity and generic quality of life) over the short-term.
A minimum of one hundred and forty subjects (minimum 70 per group) with osteoarthritis and aged 50-75 years will be included at UK/international hospitals.
Study duration is 2 years and patients will complete standard knee outcome scores plus radiological evaluation.
Subjects would receive one of the study devices regardless of their involvement in the study, and apart from (possible)additional visits, x-rays and/or questionnaires, treatment and follow-up care will be as per the care they would receive outside of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sigma CR150 | Active comparator | Device: Sigma CR150Sigma CR150 femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing). |
| Sigma CR | Active comparator | Device: Sigma CRSigma CR femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- i)Male or female subjects, aged between 50 and 75 years inclusive.
- ii)Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects defined by the Investigator as ASA Grade I or II.
- Subjects with a primary diagnosis of osteoarthritis.
Key exclusion criteria (19 listed)
- Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical investigation with an investigational product in the last month.
- Subjects who are currently involved in any injury litigation claims.
- Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
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 |
|---|---|---|
| Sigma CR150Also: PFC Sigma CR150Sigma CR150 femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing). | Device | Sigma CR150 |
| Sigma CRAlso: PFC Sigma CRSigma CR femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing). | Device | Sigma CR |
Primary outcome
Percentage of Knees Who Survived at 2 Years Post-operative
Time frame: 2 Years
The Kaplan-Meier success rate at 24-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no components revised for any reason) was censored at the time of last follow-up.
33 secondary outcomes
Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years
Time frame: Pre-operative baseline to 2 years
Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year
Time frame: Pre-operative baseline to 1 year
Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years
Time frame: 2 years
Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years
Time frame: 1 years
Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years
Time frame: 2 years
Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 1 Years
Time frame: 1 year
Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 2 Years
Time frame: 2 year
Knee Injury and Osteoarthritis Outcome - Sport and Recreation Subscore - 1 Years
Time frame: 1 year
Knee Injury and Osteoarthritis Outcome Sport and Recreation Subscore - 2 Years
Time frame: 2 year
Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 1 Years
Time frame: 1 year
Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 2 Years
Time frame: 2 years
Change From Baseline in Goniometer Measured Maximum Passive Flexion at 1 Year.
Time frame: 1 year
Change From Baseline in Goniometer Measured Maximum Passive Extension at 1 Year
Time frame: 1 year
Change From Baseline in Goniometer Measured Maximum Passive Extension at 2 Years
Time frame: 2 year
Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 1 Year
Time frame: 1 year
Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 2 Years.
Time frame: 2 years
Number of Participants With Flexion Contracture at 1 Year
Time frame: 1 years
Number of Participants With Flexion Contracture at 2 Years
Time frame: 2 years
Total Knee Society Score at 1 Year
Time frame: 1 year
Total Knee Society Knee Score at 2 Years
Time frame: 2 years
Anatomic Alignment Angle
Time frame: 1 year time point
Anatomic Alignment Angle
Time frame: 2 year time point
Alignment - Femoral Component to Anatomic Angle.
Time frame: 1 year time point
Alignment - Femoral Component to Anatomic Angle
Time frame: 2 year time point
Alignment - Tibial Component to Anatomic Angle
Time frame: 1 year time point
Alignment - Tibial Component to Anatomic Angle
Time frame: 2 year time point
Alignment - Femoral Component Flexion
Time frame: 1 year time point
Alignment - Femoral Component Flexion
Time frame: 2 year time point
Alignment - Tibial Posterior Slope
Time frame: 1 year time point
Alignment - Tibial Posterior Slope
Time frame: 2 year time point
Number of Subjects With Radiolucencies - Femoral Component
Time frame: 6 to 12 week and 24 month intervals
Number of Subjects With Radiolucencies - Tibial Component
Time frame: 6 weeks to 24 months
Radiographic Evaluation of Maximum Flexion
Time frame: 1 year time point
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoarthritis
Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Hybrid Closed Wedge High Tibial Osteotomy
Patello-femoral Osteoarthritis
Recruiting
Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis
Ankle Osteoarthritis, Foot Osteoarthritis
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.
Gautam Chakrabarty, FRCS Orth. principal investigator
Calderdale and Huddersfield Foundation NHS Trust
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sigma CR150 and Sigma CR in people with Osteoarthritis, run by DePuy International at 4 sites in 3 countries.
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 7 inclusion and 19 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, India, Singapore. 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?
Yes. Results are posted in the registry (first posted 31 May 2019). 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?
Percentage of Knees Who Survived at 2 Years Post-operative (time frame: 2 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 28 Aug 2019.