Sigma CR150 Versus Sigma CR Knee RCT

NCT01418378 | Completed Phase 4 Results

• 1 other identifier: CT07/04
• Study Type: interventional
• Target: 191
• Locations: 3 countries
• Sites: 4

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 The newer device has been in clinical use with good short-term(unpublished) outcomes since becoming commercially available in January 2009.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

Conditions

Osteoarthritis

Keywords

Sigma; cruciate; retaining; fixed; primary; total; knee; arthroplasty; cemented; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 Years

Secondary Outcomes (33)

• Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years

  Pre-operative baseline to 2 years

• Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year

  Pre-operative baseline to 1 year

• Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years

  2 years

• Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years

  1 years

• Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years

  2 years

Study Arms (2)

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).

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).

Device: Sigma CR

Interventions

Sigma CR150 DEVICE

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).

Also known as: PFC Sigma CR150

Sigma CR150

Sigma CR DEVICE

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).

Also known as: PFC Sigma CR

Sigma CR

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (4)

Sunshine Hospitals

Secunderabad, Andhra Pradesh, 500003, India

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Victoria Hospital

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

Calderdale Royal Hospital

Halifax, West Yorkshire, HX3 0PW, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Many subjects had last visit before 2yrs from date of surgery-KM survivorship estimate calculated at 1.8 years when 40 knees left in study. Subject data not available for every outcome- numbers analyzed vary between outcomes and Participant Flow.

Results Point of Contact

• Title: Dave Whalen
• Organization: DePuy Synthes

dwhalen@its.jnj.com

574-372-7028

Study Officials

• Gautam Chakrabarty, FRCS Orth.

  Calderdale and Huddersfield Foundation NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 17, 2011
• Study Start: August 3, 2011
• Primary Completion: February 17, 2016
• Study Completion: February 17, 2016
• Last Updated: August 28, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-07

Locations

SG (1); GB (2); IN (1)