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Sigma CR150 Versus Sigma CR Knee RCT

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01418378
First received: August 9, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 The newer device has been in clinical use with good short-term(unpublished) outcomes since becoming commercially available in January 2009.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.


Condition Intervention Phase
Osteoarthritis
Device: Sigma CR150
Device: Sigma CR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Survivorship [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    The primary survivorship endpoint will be revision of any component (including insert) for any reason.


Secondary Outcome Measures:
  • KOOS [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment in each KOOS domain

  • Knee Society Score - Knee Evaluation [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment in Knee Society Knee Score

  • Radiographic evaluation [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    Comparative evaluation of radiographic variables to assess alignment, component position and radiolucencies

  • Comparative Flexion [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Measurement of passive flexion, comparative change from baseline (pre-op) to post-operative assessment

  • Patient Satisfaction [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Mean patient satisfaction at each post-operative assessment

  • Survivorship [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    • For the revision of any component (including insert) for reasons other than infection.
    • For the revision of the femoral component only, for reasons other than infection.

  • KOOS [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment in each KOOS domain

  • Knee Society Score - Knee Evaluation [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Mean change from baseline (pre-op) to each post-operative assessment in Knee Society Knee Score

  • Survivorship [ Time Frame: 2 Year ] [ Designated as safety issue: Yes ]
    • For the revision of any component (including insert) for reasons other than infection.
    • For the revision of the femoral component only, for reasons other than infection.

  • Comparative Flexion [ Time Frame: 2 Year ] [ Designated as safety issue: No ]
    Measurement of passive flexion, comparative change from baseline (pre-op) to post-operative assessment

  • Radiographic evaluation [ Time Frame: 2 Year ] [ Designated as safety issue: Yes ]
    Comparative evaluation of radiographic variables to assess alignment, component position and radiolucencies


Other Outcome Measures:
  • KOOS - flexion related questions [ Time Frame: 1-year ] [ Designated as safety issue: No ]
    the flexion-related questions of the KOOS will also be analysed separately

  • KOOS - flexion related questions [ Time Frame: 2-year ] [ Designated as safety issue: No ]
    the flexion-related questions of the KOOS will also be analysed separately

  • Patella Score [ Time Frame: 1-year ] [ Designated as safety issue: No ]
    The Patella Score provides an assessment of patellofemoral joint pain and function and contains four variables: Anterior Knee Pain, Quadriceps Strength, Ability to Rise from Chair and Stair Climbing.

  • Patella Score [ Time Frame: 2-year ] [ Designated as safety issue: No ]
    The Patella Score provides an assessment of patellofemoral joint pain and function and contains four variables: Anterior Knee Pain, Quadriceps Strength, Ability to Rise from Chair and Stair Climbing.

  • EQ-5D [ Time Frame: 1-year ] [ Designated as safety issue: No ]
    The EQ-5D assessment has been included as a measure of generic health-related quality of life and is used by the subject to indicate their perception of their health state on the day of completion.

  • EQ-5D [ Time Frame: 2-year ] [ Designated as safety issue: No ]
    The EQ-5D assessment has been included as a measure of generic health-related quality of life and is used by the subject to indicate their perception of their health state on the day of completion.

  • Patient Satisfaction [ Time Frame: 1-year ] [ Designated as safety issue: No ]
    patient satisfaction will be evaluated via two simple questions at post-operative assessments.

  • Patient Satisfaction [ Time Frame: 2-year ] [ Designated as safety issue: No ]
    patient satisfaction will be evaluated via two simple questions at post-operative assessments.

  • UCLA Activity Score [ Time Frame: 1-year ] [ Designated as safety issue: No ]
    The UCLA Activity Scale will be collected to assess pre- and post-operative activity levels. It consists of one question, requiring the patient to describe their activity level.

  • UCLA Activity Score [ Time Frame: 2-year ] [ Designated as safety issue: No ]
    The UCLA Activity Scale will be collected to assess pre- and post-operative activity levels. It consists of one question, requiring the patient to describe their activity level.


Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Device: 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).
Other Name: PFC Sigma CR150
Active Comparator: 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).
Device: 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).
Other Name: PFC Sigma CR

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

iii) 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.

iv) Subjects defined by the Investigator as ASA Grade I or II.

v) Subjects with a primary diagnosis of osteoarthritis.

vi) Subjects who require a primary total knee arthroplasty.

vii) Subjects who can achieve active flexion of 90 degrees.

Exclusion Criteria:

i) 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.

ii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

iii) Subjects who have participated in a clinical investigation with an investigational product in the last month.

iv) Subjects who are currently involved in any injury litigation claims.

v) Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.

vi) Subjects with a fixed flexion deformity of over 20 degrees.

vii) Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).

viii) Subjects who cannot flex their hip to 90 degrees.

ix) Subjects with a BMI of 35 or above.

x) Subjects defined by the Investigator as ASA Grade III-V.

xi) Subjects who are identified pre-operatively as having bone defects which require augmentation.

xii) Subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, ORIF or with previous fracture in the knee joint.

xiii) Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.

xiv) Subjects who have undergone contralateral total knee arthroplasty during the previous 6 months.

xv) Subjects who in the opinion of the Investigator require patellar resurfacing.

Intra-operative exclusion criteria:

i) Subjects who have uncontained bone defects or defects bigger than 8 mm3 and/or require augmentation.

ii) Subjects who are not suitable to receive both the study and comparator devices.

iii) Subjects who require patellar resurfacing

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418378

Locations
India
Sunshine Hospitals
Secunderabad, Andhra Pradesh, India, 500003
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
United Kingdom
Victoria Hospital
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Calderdale Royal Hospital
Halifax, West Yorkshire, United Kingdom, HX3 0PW
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Gautam Chakrabarty, FRCS Orth. Calderdale and Huddersfield Foundation NHS Trust
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT01418378     History of Changes
Other Study ID Numbers: CT07/04
Study First Received: August 9, 2011
Last Updated: June 24, 2014
Health Authority: United Kingdom: Department of Health
United Kingdom: Food Standards Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee
India: Central Drugs Standard Control Organization
India: Department of Atomic Energy
India: Drugs Controller General of India
India: Indian Council of Medical Research
India: Institutional Review Board
India: Ministry of Health
India: Ministry of Science and Technology
India: Science and Engineering Research Council
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority

Keywords provided by DePuy International:
Sigma
cruciate
retaining
fixed
primary
total
knee
arthroplasty
cemented
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 23, 2014