PFC Sigma Fixed and Mobile Knee Study

NCT00208325 | Terminated Phase 4 Results

• 1 other identifier: CT 9923
• Study Type: interventional
• Target: 754
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm

  Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.

  1 year

• To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm

  Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.

  1 year

• To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm

  Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.

  Change from pre-op to 1 year

• To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm

  Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.

  Change from pre-op to 1 year

Secondary Outcomes (47)

• To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm

  Change from pre-op to 2 years

• To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm

  Change from pre-op to 2 years

• To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm

  Change from pre-op to 5 years

• To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm

  Change from pre-op to 2 years

• To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm

  Change from pre-op to 2 years

Study Arms (4)

PFC Sigma Fixed Bearing PCL Sacrificed

OTHER

PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed

Device: P.F.C Sigma Fixed Bearing total knee system

PFC Sigma RP PCL Sacrificed

ACTIVE COMPARATOR

PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed

Device: P.F.C Sigma RP Mobile Bearing knee system

PFC Sigma Fixed Bearing PCL Retained

OTHER

PFC Sigma Fixed Bearing Total Knee System with PCL Retained

Device: P.F.C Sigma Fixed Bearing total knee system

PFC Sigma RP PCL Retained

ACTIVE COMPARATOR

PFC Sigma Rotating Platform Total Knee System with PCL Retained

Device: P.F.C Sigma RP Mobile Bearing knee system

Interventions

P.F.C Sigma Fixed Bearing total knee system DEVICE

Orthopaedic implant for total knee replacement

PFC Sigma Fixed Bearing PCL Retained; PFC Sigma Fixed Bearing PCL Sacrificed

P.F.C Sigma RP Mobile Bearing knee system DEVICE

Orthopaedic implant for total knee replacement

PFC Sigma RP PCL Retained; PFC Sigma RP PCL Sacrificed

Eligibility Criteria

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

You may qualify if:

• Male or female subjects may be recruited to the evaluation.
• Age - there are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation.
• Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
• Subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
• Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing knee system and who are suitable for patella resurfacing.

You may not qualify if:

• Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• Patients who require revision total knee arthroplasty surgery.
• Patients with any tibial deformity requiring tibial component augmentation.
• Patients whom, in the opinion of the Clinical Investigator, require a constrained prosthesis.
• Patients with Rheumatoid Arthritis.
• Patients with a pathology which, in the opinion of the Clinical Investigator, will adversely affect healing.
• Patients with other disorders which, in the opinion of the Clinical Investigator, will / could impair rehabilitation.
• Contra-indications for use of the device, as detailed in the package insert.
• Women who are pregnant.
• Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
• Subjects who are currently involved in another clinical study with an investigational product.
• Subjects who are currently involved in any injury litigation claims.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (4)

Glasgow Royal Infirmary

Glasgow, United Kingdom

Location

Glasgow Western Infirmary

Glasgow, United Kingdom

Location

Northampton General Hospital

Northampton, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1LB, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Kimberly Dwyer, Ph.D, CCRA
• Organization: DePuy International

kdwyer2@its.jnj.com

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2000
• Primary Completion: January 1, 2009
• Study Completion: September 1, 2010
• Last Updated: September 13, 2016
• Results First Posted: July 20, 2016

Record last verified: 2016-08

Locations

GB (4)