OsteoarthritisPhase 4NCT00837447

Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses

A Phase 4 study testing Total knee replacement with NexGen CR knee prosthesis and Total knee replacement(TKR) with Nexgen CR-flex in people with Osteoarthritis, run by Ewha Womans University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this prospective, randomized study was to compare pain, functional outcome and ranges of motion of the knees in patients receiving either a standard posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis. Read more about this study

Who is it for?: Any age
Conditions the study is for: Osteoarthritis
What is being tested?: Total knee replacement with NexGen CR knee prosthesis and Total knee replacement(TKR) with Nexgen CR-flex
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: No sites listed yet
Study dates: Oct 2004to Mar 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties

Who cannot join

inflammatory arthritis
osteoarthritis of the hip causing pain or restricted mobility
a foot or ankle disorder which limited walking
dementia or a neurological disorder including a past history of stroke which affected mobility

About this study

Official title: Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses A Prospective, Randomized Study

Read the detailed description

The main goals of total knee arthroplasty are pain relief and improvement of function and range of motion. The purpose of this study was to compare ranges of motion of the knees in patients receiving either a standard posterior crucaite-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

Conditions: Osteoarthritis
Being tested: Total knee replacement with NexGen CR knee prosthesis, Total knee replacement(TKR) with Nexgen CR-flex
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Total knee replacement with NexGen CR knee prosthesisDevice
Also called NexGen CR
comparison of functional outcome in patients receiving either NexGen posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis
Total knee replacement(TKR) with Nexgen CR-flexDevice
Also called Nexgen CR-flex
TKR using Nexgen CR-flex implant

Study groups in NCT00837447
Study group	Role	What they receive
NexGen CR knee prosthesis	Active comparator	side of knee operated with total knee replacement with Nexgen CR prosthesis Receives: Device: Total knee replacement with NexGen CR knee prosthesis
NexGen CR-Flex knee prosthesis	Active comparator	side of knee operated with total knee arthroplasty using Nexgen CR-flex prosthesis Receives: Device: Total knee replacement(TKR) with Nexgen CR-flex

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Knee Society Knee Score
change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome.
Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points
Measured: baseline and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004Mar 2008

First posted5 Feb 2009 (estimated)
Study startOct 2004
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00837447
Sponsor's protocol ID: 2007-7
Status last verified: Mar 2013
First submitted: 4 Feb 2009
Last updated: 10 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses A Prospective, Randomized Study
ClinicalTrials.gov ID: NCT00837447
Acronym / sponsor ID: 2007-7
Conditions: Osteoarthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Ewha Womans UniversityUniversity, hospital or other
Study start: Oct 2004
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 5 Feb 2009 (estimated)
Results: Posted 10 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NexGen CR knee prosthesis	Active comparator	Device: Total knee replacement with NexGen CR knee prosthesisside of knee operated with total knee replacement with Nexgen CR prosthesis
NexGen CR-Flex knee prosthesis	Active comparator	Device: Total knee replacement(TKR) with Nexgen CR-flexside of knee operated with total knee arthroplasty using Nexgen CR-flex prosthesis

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties

Key exclusion criteria (4 listed)

inflammatory arthritis
osteoarthritis of the hip causing pain or restricted mobility
a foot or ankle disorder which limited walking
dementia or a neurological disorder including a past history of stroke which affected mobility

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 replacement with NexGen CR knee prosthesisAlso: NexGen CRcomparison of functional outcome in patients receiving either NexGen posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis	Device	NexGen CR knee prosthesis
Total knee replacement(TKR) with Nexgen CR-flexAlso: Nexgen CR-flexTKR using Nexgen CR-flex implant	Device	NexGen CR-Flex knee prosthesis

Primary outcome

Change in Knee Society Knee Score
Time frame: baseline and 3 years
change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome. Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points

Results and safety

Results posted to the registry on 10 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NexGen CR and CR-flex Knee Prosthesis	54	54

Primary outcome: Change in Knee Society Knee Score

Time frame: baseline and 3 years. Mean (Standard Deviation). Unit: scores on a scale

Measure	High-Flexion Posterior Cruciate Retaining TKA n = 54	High-Flexion Posterior Cruciate Scrificing TKA n = 54
Value	93.9 (4.66)	93.7 (4.53)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NexGen CR and CR-flex Knee Prosthesis	0 of 54 (0%)	0 of 54 (0%)	Not reported

Limitations and caveats (from the sponsor): First, the knee scoring system is prone to intraobserver variability. Second, we had no interobserver variability and this could have lead to bias in interpreting radiographic results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Young-Hoo Kim, MD study director

Ewha Womans University Mokdong Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Total knee replacement with NexGen CR knee prosthesis and Total knee replacement(TKR) with Nexgen CR-flex in people with Osteoarthritis, run by Ewha Womans University.

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 1 inclusion and 4 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 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Knee Society Knee Score (time frame: baseline and 3 years). 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 NCT00837447.

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 10 Apr 2013.