Functional Evaluation of a Standard and a High-flexion Knee Prosthesis Using Thigh-calf Contact Force Measurements

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

In-vivo Study Investigating the Difference in Functional Outcome Between Two Types of Knee Prostheses: the Sigma FB (Depuy, J&J, UK; Standard Implant) and the Sigma RP-F (Depuy, J&J, UK; High-flexion Implant)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899041
• Other study ID #: ORL-FK-08/02
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: November 7, 2013
• Start date: October 2008
• Est. completion date: October 2013

Study information

• Verified date: December 2011
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether subjects receiving a high-flexion knee prosthesis show a better knee function than patients receiving a standard knee prosthesis. Thigh-calf contact force measurements are used to quantify knee function. The investigators' hypothesis is that high-flexion knees show a better knee function.

Description:

Study title:

Functional evaluation of a standard and a high-flexion knee prosthesis using thigh-calf contact force measurements.

Objective:

The objective of this study is to investigate whether subjects receiving a high flexion knee prosthesis (Sigma RP-F, J&J, UK) show a better knee function than patients receiving a standard knee prosthesis (Sigma FB, J&J, UK).

Study Design:

Prospective double blind randomized study.

Study population:

Subjects who will receive total knee arthroplasty (TKA) because of invalidating gonarthritis based on primary osteoarthritis or rheumatic disorders or trauma.

Intervention:

• 28 subjects will receive the standard Sigma FB knee prosthesis.

• 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients receiving a total knee replacement due to disabling gonarthrosis (cartilage damage):

• Primary due to osteo-arthritis

• Secondary due to rheumatoid arthritis or trauma

Exclusion Criteria:

• Patients suffering from juvenile rheuma

• Patients suffering from hemophilia

• Patients that are incapable to give informed consent

• Patients who receive a total knee replacement due to an oncological resection

• Patients who have received a total knee replacement on the contralateral leg

• Patients who have disabling gonarthrosis on both legs

• Patients having a BMI < 25 kg/m^2

• Patients who have to receive a different prosthesis than used in this study for biomechanical reasons (e.g. revision prosthesis)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Procedure:
• Total Knee Arthroplasty (TKA)
28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.

Locations

Country	Name	City	State
Netherlands	Canisius-Wilhelmina Hospital	Nijmegen

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Canisius-Wilhelmina Hospital, Johnson & Johnson Medical BV, The Netherlands

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Zelle J, Barink M, Loeffen R, De Waal Malefijt M, Verdonschot N. Thigh-calf contact force measurements in deep knee flexion. Clin Biomech (Bristol, Avon). 2007 Aug;22(7):821-6. Epub 2007 May 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thigh-calf contact force		pre-op and 1-year post-op	No
Secondary	Passive/active maximal knee flexion angle		pre-op and 1-year post-op	No
Secondary	BMI, weight and length		pre-op and 1-year post-op	No
Secondary	Thigh and calf circumference		pre-op and 1-year post-op	No
Secondary	IKS, WOMAC and VAS (pain/satisfaction) score		pre-op and 1-year post-op	No