Knee OsteoarthritisNCT01176292

Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)

A study testing Rotating Platform High-Flex Cruciate Substituting TKA and Rotating Platform Cruciate Substituting TKA in people with Knee Osteoarthritis, run by Anderson Orthopaedic Research Institute.

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 goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Rotating Platform High-Flex Cruciate Substituting TKA and Rotating Platform Cruciate Substituting TKA
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: No sites listed yet
Study dates: Aug 2007to May 2012
Phase: Interventional
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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 40 to 75 years old
Primary diagnosis of osteoarthritis of the knee
Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.

Who cannot join

Pregnant or lactating female subjects
Patients with post-traumatic or inflammatory arthritis
Patients with a fixed flexion contracture of greater than 20 degrees
Patients with advanced hip, spine, or ankle disease
Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues

About this study

Official title: A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty

The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.

Conditions: Knee Osteoarthritis
Being tested: Rotating Platform High-Flex Cruciate Substituting TKA, Rotating Platform Cruciate Substituting TKA
Keywords: total knee replacement, high flexion, range of motion, rotating platform, TKA
Medical subject headings: Osteoarthritis, Knee

What participants receive

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

Rotating Platform High-Flex Cruciate Substituting TKADevice
Rotating Platform Cruciate Substituting TKADevice

Study groups in NCT01176292
Study group	Role	What they receive
Rotating Platform High-Flex Cruciate Substituting TKA	Other	Not described Receives: Device: Rotating Platform High-Flex Cruciate Substituting TKA
Rotating Platform Cruciate Substituting TKA	Other	Not described Receives: Device: Rotating Platform Cruciate Substituting TKA

What is being measured

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

Clinical Flexion
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Measured: Preoperative, 4-6 weeks
Clinical Flexion
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Measured: 4-6 months
Clinical Flexion
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Measured: 1 year

Secondary outcomes (4)

Radiographic Flexion
Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.
Measured: preoperative, 4-6 weeks
Radiographic Flexion
Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.
Measured: 1 year
Knee Society Score (KSS)
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome.
Measured: 1 year
Oxford Knee Score
A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome.
Measured: 1 year

Timeline

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

Aug 2007May 2012

First posted6 Aug 2010 (estimated)
Study startAug 2007
Primary completionMay 2012
Study completionMay 2012

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 Knee 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01176292
Sponsor's protocol ID: AORI2010-0104
Status last verified: Nov 2020
First submitted: 26 Jul 2010
Last updated: 23 Nov 2020
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

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT01176292
Acronym / sponsor ID: AORI2010-0104
Conditions: Knee Osteoarthritis
Keywords: total knee replacement, high flexion, range of motion, rotating platform, TKA
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Anderson Orthopaedic Research InstituteUniversity, hospital or other
Collaborators: DePuy Orthopaedics
Study start: Aug 2007
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 6 Aug 2010 (estimated)
Results: Posted 31 Aug 2015

Clinical summary

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

The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Rotating Platform High-Flex Cruciate Substituting TKA	Other	Device: Rotating Platform High-Flex Cruciate Substituting TKA
Rotating Platform Cruciate Substituting TKA	Other	Device: Rotating Platform Cruciate Substituting TKA

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 40 to 75 years old
Primary diagnosis of osteoarthritis of the knee
Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.

Key exclusion criteria (5 listed)

Pregnant or lactating female subjects
Patients with post-traumatic or inflammatory arthritis
Patients with a fixed flexion contracture of greater than 20 degrees
Patients with advanced hip, spine, or ankle disease
Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues

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
Rotating Platform High-Flex Cruciate Substituting TKA	Device	Rotating Platform High-Flex Cruciate Substituting TKA
Rotating Platform Cruciate Substituting TKA	Device	Rotating Platform Cruciate Substituting TKA

Primary outcome

Clinical Flexion
Time frame: Preoperative, 4-6 weeks
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Clinical Flexion
Time frame: 4-6 months
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.
Clinical Flexion
Time frame: 1 year
Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.

4 secondary outcomes

Radiographic Flexion
Time frame: preoperative, 4-6 weeks
Radiographic Flexion
Time frame: 1 year
Knee Society Score (KSS)
Time frame: 1 year
Oxford Knee Score
Time frame: 1 year

Results and safety

Results posted to the registry on 31 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rotating Platform High-Flex Cruciate Substituting TKA	71	66
Rotating Platform Cruciate Substituting TKA	71	62

Primary outcome: Clinical Flexion

Time frame: Preoperative, 4-6 weeks. Mean (Standard Deviation). Unit: degrees

Measure	Rotating Platform High-Flex Cruciate Substituting TKA n = 70	Rotating Platform Cruciate Substituting TKA n = 68
Clinical flexion - preoperative	119.1 (13.2)	120.3 (11.2)
Clinical flexion - 4 week	112.0 (12.7)	111.3 (15.3)

Population analysed: All subjects with available data at the preoperative and 4-6 week intervals.

Primary outcome: Clinical Flexion

Time frame: 4-6 months. Mean (Standard Deviation). Unit: degrees

Measure	Rotating Platform High-Flex Cruciate Substituting TKA n = 70	Rotating Platform Cruciate Substituting TKA n = 65
Value	122.5 (8.6)	121.3 (9.6)

Population analysed: All subjects with available data at the 4-6 month interval.

Primary outcome: Clinical Flexion

Time frame: 1 year. Mean (Standard Deviation). Unit: degrees

Measure	Rotating Platform High-Flex Cruciate Substituting TKA n = 66	Rotating Platform Cruciate Substituting TKA n = 62
Value	124.2 (8.7)	124.0 (10.3)

Population analysed: All subjects with available data at the 1-year interval.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year follow-up. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rotating Platform High-Flex Cruciate Substituting TKA	7 of 71 (9.9%)	9 of 71 (12.7%)	Not reported
Rotating Platform Cruciate Substituting TKA	4 of 71 (5.6%)	3 of 71 (4.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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.

William G Hamilton, MD principal investigator

Anderson Orthopaedic Research Institute

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 5 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 23 Nov 2020. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2015). 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?

Clinical Flexion (time frame: Preoperative, 4-6 weeks). The study lists 3 primary outcomes in all. 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 NCT01176292.

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 23 Nov 2020.