Arthroplasty, Replacement, KneeNCT00899041
Functional Evaluation of a Standard and a High-flexion Knee Prosthesis Using Thigh-calf Contact Force Measurements
A study testing Total Knee Arthroplasty (TKA) in people with Arthroplasty, Replacement, Knee, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Total Knee Arthroplasty (TKA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2008to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving a total knee replacement due to disabling gonarthrosis (cartilage damage):
- Primary due to osteo-arthritis
- Secondary due to rheumatoid arthritis or trauma
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Total Knee Arthroplasty (TKA)
- Keywords
- Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Arthroplasty (TKA)Procedure or surgery
Also called Sigma RP-F, J&J, UK, Sigma FB, J&J, UK
28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Standard knee prosthesis | Active comparator | 'standard' knee prosthesis (Sigma FB, J\&J, UK). Receives: Procedure: Total Knee Arthroplasty (TKA) |
| High flexion knee prosthesis | Active comparator | 'high flexion' knee prosthesis (Sigma RP-F, J\&J, UK). Receives: Procedure: Total Knee Arthroplasty (TKA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh-calf contact force
Measured: pre-op and 1-year post-op
Secondary outcomes (4)
Passive/active maximal knee flexion angle
Measured: pre-op and 1-year post-op
BMI, weight and length
Measured: pre-op and 1-year post-op
Thigh and calf circumference
Measured: pre-op and 1-year post-op
IKS, WOMAC and VAS (pain/satisfaction) score
Measured: pre-op and 1-year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Medical BV, The Netherlands, Canisius-Wilhelmina Hospital
- Responsible party
- Sponsor
- Investigators
- Nico Verdonschot, Prof., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899041
- Sponsor's protocol ID
- ORL-FK-08/02
- Status last verified
- Dec 2011
- First submitted
- 11 May 2009
- Last updated
- 8 Nov 2013
- Results posted
- No
Publications
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.
PubMed 17512647van 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.
PubMed 28764691
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00899041
- Acronym / sponsor ID
- ORL-FK-08/02
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Johnson & Johnson Medical BV, The Netherlands, Canisius-Wilhelmina Hospital
- Study start
- Oct 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard knee prosthesis | Active comparator | Procedure: Total Knee Arthroplasty (TKA)'standard' knee prosthesis (Sigma FB, J\&J, UK). |
| High flexion knee prosthesis | Active comparator | Procedure: Total Knee Arthroplasty (TKA)'high flexion' knee prosthesis (Sigma RP-F, J\&J, UK). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving a total knee replacement due to disabling gonarthrosis (cartilage damage):
- Primary due to osteo-arthritis
- Secondary due to rheumatoid arthritis or trauma
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee Arthroplasty (TKA)Also: Sigma RP-F, J&J, UK, Sigma FB, J&J, UK28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis. | Procedure or surgery | High flexion knee prosthesis, Standard knee prosthesis |
Primary outcome
Thigh-calf contact force
Time frame: pre-op and 1-year post-op
4 secondary outcomes
Passive/active maximal knee flexion angle
Time frame: pre-op and 1-year post-op
BMI, weight and length
Time frame: pre-op and 1-year post-op
Thigh and calf circumference
Time frame: pre-op and 1-year post-op
IKS, WOMAC and VAS (pain/satisfaction) score
Time frame: pre-op and 1-year post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Background: PubMed 17512647Zelle 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.
- Derived from this study: PubMed 28764691van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nico Verdonschot, Prof. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty (TKA) in people with Arthroplasty, Replacement, Knee, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh-calf contact force (time frame: pre-op and 1-year post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00899041, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.