Status:
COMPLETED
Sigma CR150 Versus Sigma CR Knee RCT
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis
Eligibility:
All Genders
50-75 years
Phase:
PHASE4
Brief 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/accommo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 3 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2016
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT01418378
Start Date
August 3 2011
End Date
February 17 2016
Last Update
August 28 2019
Active Locations (4)
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1
Sunshine Hospitals
Secunderabad, Andhra Pradesh, India, 500003
2
Singapore General Hospital
Singapore, Singapore, 169608
3
Victoria Hospital
Kirkcaldy, Fife, United Kingdom, KY2 5AH
4
Calderdale Royal Hospital
Halifax, West Yorkshire, United Kingdom, HX3 0PW