Clinical trial NCT00899041: Functional Evaluation of a Standard and a High-flexion Knee Prosthesis Using Thigh-calf Contact Force Measurements
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: Prosthesis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Medical BV, The Netherlands
name: Canisius-Wilhelmina Hospital
First posted: 2009-05-12
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility 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)

Primary outcomes:
measure: Thigh-calf contact force
timeFrame: pre-op and 1-year post-op
Secondary outcomes:
measure: Passive/active maximal knee flexion angle
timeFrame: pre-op and 1-year post-op
measure: BMI, weight and length
timeFrame: pre-op and 1-year post-op
measure: Thigh and calf circumference
timeFrame: pre-op and 1-year post-op
measure: IKS, WOMAC and VAS (pain/satisfaction) score
timeFrame: pre-op and 1-year post-op
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Hospital
Study officials:
affiliation: Radboud University Medical Center
name: Nico Verdonschot, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zelle J, Barink M, Loeffen R, De Waal Malefijt M, Verdonschot N. Thigh-calf contact force measurements in deep knee flexion. Clin Biomech (Bristol). 2007 Aug;22(7):821-6. doi: 10.1016/j.clinbiomech.2007.03.009. Epub 2007 May 18.
citation: van der Ven PJP, van de Groes S, Zelle J, Koeter S, Hannink G, Verdonschot N. Kneeling and standing up from a chair as performance-based tests to evaluate knee function in the high-flexion range: a randomized controlled trial comparing a conventional and a high-flexion TKA design. BMC Musculoskelet Disord. 2017 Aug 1;18(1):324. doi: 10.1186/s12891-017-1657-3.