Functional outcome of the P.F.C. Sigma® RP-F knee system and the P.F.C. Sigma® knee system

Not Applicable

Completed

• Conditions: Osteoarthritis of the knee; Musculoskeletal Diseases

• Registration Number: ISRCTN64287972
• Lead Sponsor: South Tees Hospitals NHS Trust (UK)

Brief Summary

2010 Results article in https://pubmed.ncbi.nlm.nih.gov/19898821/ (added 13/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-12
• Study Completion: 2019-03-31
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Male or female subjects, aged 18 years and older.
2. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
3. 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.
4. Subjects who present with idiopathic or posttraumatic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with P.F.C. Sigma® RP-F and P.F.C. Sigma® knee systems.
5. Subjects, who in the opinion of the Clinical Investigator, are considered to be suitable for treatment with both investigational devices, according to the indications specified in the package insert leaflet.

Exclusion Criteria

1. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
2. Subjects with a Body Mass Index (BMI) >35.
3. Subjects with a known history of poor compliance to medical treatment.
4. Women who are pregnant.
5. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
6. Subjects involved in Medical-Legal claims.
7. Intra-operative use of augmentation devices.
8. Intra-operative decision to resurface the patella based on clinical indication.
9. Revision of an existing knee implant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of the difference in the mean ROM between participants receiving a primary total knee replacement with either the P.F.C. Sigma® RP-F or the P.F.C. Sigma® knee system at 12 months.

Secondary Outcome Measures

Name	Time	Method
<br> Comparative evaluation of any post-operative variation between participants receiving a primary total knee replacement with either the P.F.C. Sigma® RP-F or the P.F.C. Sigma® knee system in change from baseline at each post operative time point (3, 12, 60 and 120 months) in terms of:<br> 1. Functional recovery using the Oxford Knee Score<br> 2. Quality of life assessed by the Short Form-12 (SF-12v2) questionnaire<br> 3. American Knee Society Score<br> 4. Survivorship analysis of the two groups at 60 and 120 months post-operatively<br>