NCT00899041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 8, 2013

Status Verified

December 1, 2011

Enrollment Period

4.9 years

First QC Date

May 11, 2009

Last Update Submit

November 7, 2013

Conditions

Arthroplasty, Replacement, Knee

Keywords

Prosthesis

Outcome Measures

Primary Outcomes (1)

  • Thigh-calf contact force

    pre-op and 1-year post-op

Secondary Outcomes (4)

  • Passive/active maximal knee flexion angle

    pre-op and 1-year post-op

  • BMI, weight and length

    pre-op and 1-year post-op

  • Thigh and calf circumference

    pre-op and 1-year post-op

  • IKS, WOMAC and VAS (pain/satisfaction) score

    pre-op and 1-year post-op

Study Arms (2)

Standard knee prosthesis

ACTIVE COMPARATOR

'standard' knee prosthesis (Sigma FB, J\&J, UK).

Procedure: Total Knee Arthroplasty (TKA)

High flexion knee prosthesis

ACTIVE COMPARATOR

'high flexion' knee prosthesis (Sigma RP-F, J\&J, UK).

Procedure: Total Knee Arthroplasty (TKA)

Interventions

Total Knee Arthroplasty (TKA)PROCEDURE

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

Also known as: Sigma RP-F, J&J, UK, Sigma FB, J&J, UK
High flexion knee prosthesisStandard knee prosthesis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving a total knee replacement due to disabling gonarthrosis (cartilage damage):
  • Primary due to osteo-arthritis
  • Secondary due to rheumatoid arthritis or trauma

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canisius-Wilhelmina Hospital

Nijmegen, 6532 SZ, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 17512647BACKGROUND

  • 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.

    PMID: 28764691DERIVED

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Nico Verdonschot, Prof.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 12, 2009

Study Start

October 1, 2008

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

November 8, 2013

Record last verified: 2011-12

Locations

NL(1)