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

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ClinicalTrials.gov Identifier: NCT00899041
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : November 8, 2013
Sponsor:
Collaborators:
Johnson & Johnson Medical BV, The Netherlands
Canisius-Wilhelmina Hospital
Information provided by (Responsible Party):
Radboud University

Brief 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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Procedure: Total Knee Arthroplasty (TKA) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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)
Study Start Date : October 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard knee prosthesis
'standard' knee prosthesis (Sigma FB, J&J, UK).
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.
Other Names:
  • Sigma RP-F, J&J, UK
  • Sigma FB, J&J, UK

Active Comparator: High flexion knee prosthesis
'high flexion' knee prosthesis (Sigma RP-F, J&J, UK).
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.
Other Names:
  • Sigma RP-F, J&J, UK
  • Sigma FB, J&J, UK




Primary Outcome Measures :
  1. Thigh-calf contact force [ Time Frame: pre-op and 1-year post-op ]

Secondary Outcome Measures :
  1. Passive/active maximal knee flexion angle [ Time Frame: pre-op and 1-year post-op ]
  2. BMI, weight and length [ Time Frame: pre-op and 1-year post-op ]
  3. Thigh and calf circumference [ Time Frame: pre-op and 1-year post-op ]
  4. IKS, WOMAC and VAS (pain/satisfaction) score [ Time Frame: pre-op and 1-year post-op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899041


Locations
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Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, Netherlands, 6532 SZ
Sponsors and Collaborators
Radboud University
Johnson & Johnson Medical BV, The Netherlands
Canisius-Wilhelmina Hospital
Investigators
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Principal Investigator: Nico Verdonschot, Prof. Radboud University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00899041    
Other Study ID Numbers: ORL-FK-08/02
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: December 2011
Keywords provided by Radboud University:
Prosthesis