OsteoarthritisNCT00289081
Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses
A study testing Total Knee Replacement in people with Osteoarthritis and Arthritis, Rheumatoid, run by DePuy Orthopaedics at 4 sites in United States.
Trial summary
The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Arthritis, Rheumatoid, Avascular Necrosis of Bone
- What is being tested?
- Total Knee Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2001to Jun 2006
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis
- Rheumatoid arthritis
- Avascular necrosis (AVN) of bone
- Other inflammatory arthritis
- Post-traumatic arthritis
- Juvenile rheumatoid arthritis
Who cannot join
- Prior ipsilateral TKA
- Metabolic disorders
- Joint replacement due to autoimmune disorders
- History of recent/active joint sepsis
- Charcot neuropathy
- Psycho-social disorders that would limit rehabilitation
Show all 9Show fewer
- Greater than 75 years of age at the time of surgery
- Severe diabetes mellitus
- Skeletal immaturity
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Cleveland Heights, Ohio, 44118
West Coast Orthopaedic Specialists
Crystal River, Florida, 34429
Study site
La Jolla, California, 92037
Study site
Melbourne, Florida, 32901
About this study
Official title: Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting
The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
Read the detailed description
The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid, Avascular Necrosis of Bone, Post-traumatic Arthritis, Rheumatoid Arthritis
- Being tested
- Total Knee Replacement
- Keywords
- Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ReplacementDevice
Also called P.F.C.® Sigma™ RP Cruciate Retaining Knee implant
Rotating Platform (RP) Cruciate Retaining Knee implant
Total knee replacementDevice
Also called P.F.C.® Sigma™ RP Cruciate Substituting Knee implant.
Rotating Platform (RP) Cruciate Substituting Knee implant.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Rotating Platform Cruciate Retaining Knee implant Receives: Device: Total Knee Replacement |
| 2 | Active comparator | Rotating Platform Cruciate Substituting Knee implant. Receives: Device: Total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society scores
Measured: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary outcomes (4)
Complications
Measured: On-going to end of study
Revisions
Measured: On-going to end of study
Medical imaging
Measured: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
SF-12 patient outcomes
Measured: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startFeb 2001
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tammy L O'Dell, EMT, CCRA, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289081
- Sponsor's protocol ID
- SRP-1
- Status last verified
- May 2014
- First submitted
- 7 Feb 2006
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting
- ClinicalTrials.gov ID
- NCT00289081
- Acronym / sponsor ID
- SRP-1
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid, Avascular Necrosis of Bone, Post-traumatic Arthritis, Rheumatoid Arthritis
- Keywords
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 399 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 9 Feb 2006 (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 the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
Detailed description
The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Total Knee ReplacementRotating Platform Cruciate Retaining Knee implant |
| 2 | Active comparator | Device: Total knee replacementRotating Platform Cruciate Substituting Knee implant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Osteoarthritis
- Rheumatoid arthritis
- Avascular necrosis (AVN) of bone
- Other inflammatory arthritis
- Post-traumatic arthritis
Key exclusion criteria (9 listed)
- Prior ipsilateral TKA
- Metabolic disorders
- Joint replacement due to autoimmune disorders
- History of recent/active joint sepsis
- Charcot neuropathy
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 ReplacementAlso: P.F.C.® Sigma™ RP Cruciate Retaining Knee implantRotating Platform (RP) Cruciate Retaining Knee implant | Device | 1 |
| Total knee replacementAlso: P.F.C.® Sigma™ RP Cruciate Substituting Knee implant.Rotating Platform (RP) Cruciate Substituting Knee implant. | Device | 2 |
Primary outcome
Knee Society scores
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
4 secondary outcomes
Complications
Time frame: On-going to end of study
Revisions
Time frame: On-going to end of study
Medical imaging
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
SF-12 patient outcomes
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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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.
Tammy L O'Dell, EMT, CCRA study director
DePuy Orthopaedics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Replacement in people with Osteoarthritis and Arthritis, Rheumatoid, run by DePuy Orthopaedics at 4 sites in United States.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 was stopped early (reason given: Business reasons). Results are not available in the source record.
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?
Knee Society scores (time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2014.