Osteoarthritis, KneeNCT01301950
Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty
A study testing Custom Patient Instrumentation and Conventional Instruments in people with Osteoarthritis, Knee, run by DePuy Orthopaedics at 3 sites in United States.
Trial summary
This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Custom Patient Instrumentation and Conventional Instruments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2010to 1 Aug 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or female and between the ages of 18 and 80 years old, inclusive.
- Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
- Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy
- Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation, and co-operate with investigational procedures.
- Subject, who, in the opinion of the Clinical Investigator, are suitable for implantation using TruMatch™ instrumentation. For example, no femoral nails/bone plates that extend into the knee, ie. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture are consistent with TruMatch™ instrumentation.
Who cannot join
- The Subject is a woman who is pregnant or lactating.
- The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
- The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
- The Subject has previously had a prosthetic knee replacement device (any type) of the affected knee.
- The Subject requires simultaneous bilateral total knee replacements.
- The Subject had a contralateral TKA and that knee was previously entered in the study.
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- Subject in whom the surgeon intends to implant a knee prosthesis that is not in the PFC Sigma primary knee system.
- Subject who has inflammatory arthritis.
- Subject who has a Body Mass Index (BMI) of ≥ 40. (Please see Table 2-1: Definition of Terms, for BMI definition and calculation formulas).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pinnacle Orthopaedics
Bartlesville, Oklahoma, 74006
Center for Hip and Knee Surgery
Mooresville, Indiana, 46158
Commonwealth Orthopaedics
Reston, Virginia, 20190
About this study
Official title: Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch® Personalized Solutions Compared to Conventional Total Knee Arthroplasty
This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model.
Read the detailed description
The study is designed as a prospective, multi-center, controlled, non-randomized, clinical investigation to compare the efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Custom Patient Instrumentation, Conventional Instruments
- Keywords
- Arthroplasties, Knee Replacement, Arthroplasties, Replacement, Knee, Arthroplasty, Knee Replacement, Knee Replacement Arthroplasties, Knee Replacement Arthroplasty, Knee Replacement, Total, Replacement Arthroplasties, Knee, Replacement Arthroplasty, Knee, Replacement, Total Knee, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom Patient InstrumentationOther
Also called TruMatch® Personalized Solutions
TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation (CPI). TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
Conventional InstrumentsOther
Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.
| Study group | Role | What they receive |
|---|---|---|
| TruMatch® Personalized Solutions | Active comparator | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions (Custom Patient Instrumentation) Receives: Other: Custom Patient Instrumentation |
| Conventional Total Knee Replacement | Active comparator | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments Receives: Other: Conventional Instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements
Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).
Measured: Intraoperative (Time from first incision to first stitch)
Secondary outcomes (4)
Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete
Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes]
Measured: Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)
Turnover Time (Time to Clean Operating Room After Surgery is Completed)
Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes].
Measured: Intraoperative (Time to clean Operating Room after surgery is completed)
Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures
Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .
Measured: Intraoperative (Total duration of procedure)
To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study start1 May 2010
- Primary completion1 Aug 2013
- Study completion1 Aug 2013
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 Osteoarthritis, KneeStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Painter, Principal investigator, Pinnacle Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301950
- Sponsor's protocol ID
- 08004
- Status last verified
- Apr 2019
- First submitted
- 2 Dec 2010
- Last updated
- 10 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch® Personalized Solutions Compared to Conventional Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01301950
- Acronym / sponsor ID
- 08004
- Conditions
- Osteoarthritis, Knee
- Keywords
- Arthroplasties, Knee Replacement, Arthroplasties, Replacement, Knee, Arthroplasty, Knee Replacement, Knee Replacement Arthroplasties, Knee Replacement Arthroplasty, Knee Replacement, Total, Replacement Arthroplasties, Knee, Replacement Arthroplasty, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 May 2010 (actual)
- Primary completion
- 1 Aug 2013 (actual)
- Study completion
- 1 Aug 2013 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Posted 5 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model.
Detailed description
The study is designed as a prospective, multi-center, controlled, non-randomized, clinical investigation to compare the efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TruMatch® Personalized Solutions | Active comparator | Other: Custom Patient InstrumentationCruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions (Custom Patient Instrumentation) |
| Conventional Total Knee Replacement | Active comparator | Other: Conventional InstrumentsCruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is male or female and between the ages of 18 and 80 years old, inclusive.
- Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
- Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy
- Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation, and co-operate with investigational procedures.
- Subject, who, in the opinion of the Clinical Investigator, are suitable for implantation using TruMatch™ instrumentation. For example, no femoral nails/bone plates that extend into the knee, ie. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture are consistent with TruMatch™ instrumentation.
Key exclusion criteria (9 listed)
- The Subject is a woman who is pregnant or lactating.
- The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
- The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
- The Subject has previously had a prosthetic knee replacement device (any type) of the affected knee.
- The Subject requires simultaneous bilateral total knee replacements.
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 |
|---|---|---|
| Custom Patient InstrumentationAlso: TruMatch® Personalized SolutionsTruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation (CPI). TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon | Other | TruMatch® Personalized Solutions |
| Conventional InstrumentsTotal Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique. | Other | Conventional Total Knee Replacement |
Primary outcome
Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements
Time frame: Intraoperative (Time from first incision to first stitch)
Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).
4 secondary outcomes
Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete
Time frame: Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)
Turnover Time (Time to Clean Operating Room After Surgery is Completed)
Time frame: Intraoperative (Time to clean Operating Room after surgery is completed)
Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures
Time frame: Intraoperative (Total duration of procedure)
To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- 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.
Carl Painter principal investigator
Pinnacle Orthopaedics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom Patient Instrumentation and Conventional Instruments in people with Osteoarthritis, Knee, run by DePuy Orthopaedics at 3 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 5 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: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 5 Sep 2014). 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?
Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements (time frame: Intraoperative (Time from first incision to first stitch)). 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 10 Apr 2019.