Osteoarthritis, KneeNCT01108237
Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation
A study testing TruMatch™ Personalized Solutions and Total Knee Arthroplasty with Conventional Instrumentation. in people with Osteoarthritis, Knee, run by DePuy Orthopaedics at 4 sites in United States.
Trial summary
This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventional surgical… 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?
- TruMatch™ Personalized Solutions and Total Knee Arthroplasty with Conventional Instrumentation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2009to 1 Mar 2011
- 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
- Subjects meeting all of the following specific criteria will be considered for participation in the study:
- 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 has given consent to the transfer of his/her information to DePuy.
- Subject, who, in the opinion of the Clinical Investigator at the time of preoperative planning, are suitable for implantation using TruMatch™ instrumentation and whose surgical plan (patient proposal) is approved. For example, no femoral nails/bone plates that extend into the knee, i.e. 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
Who cannot join
- Subjects will be excluded from participation in the trial if they meet any of the following criteria:
- The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
- The Subject is a woman who is pregnant or lactating.
- The Subject is a known drug or alcohol abuser or has a psychological disorder that could affect follow-up care or treatment outcomes.
- 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.
Show all 12Show fewer
- The Subject has previously had a prosthetic knee replacement device (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty) of the affected knee or a previous patellectomy.
- The Subject presents ankylosis of the hip joint on the side to be treated or previous ipsilateral UTO/HTO.
- The Subject requires simultaneous bilateral total knee replacements.
- The Subject had a contralateral TKA and that knee was previously entered in the study.
- Subject in whom the surgeon intends to implant a knee prosthesis that is not the cruciate retaining or posterior substituting PFC Sigma total knee arthroplasty.
- Subjects who have inflammatory arthritis
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Towson Orthopaedic Associates
Baltimore, Maryland, 21204
OrthoCarolina
Charlotte, North Carolina, 28207
Valley Orthopaedic Associates
Renton, Washington, 98055-5791
Summit Orthopaedics, LTD
Saint Paul, Minnesota, 55102
About this study
Official title: Comparison of In Vivo Alignment With TruMatch™ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKR)
This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventional surgical techniques.
The purpose of this investigation is to determine whether TruMatch™ alignment is non-inferior to alignment achieved with conventional instrumentation. This investigation will compare long leg alignment in total knee replacement achieved by the two types of procedures. Radiographic analysis will be performed by the same independent radiographic reviewer as the historical control study.
Read the detailed description
The study is designed as a prospective, multi-center, non-randomized, clinical investigation to determine whether TruMatch™ alignment is non-inferior to alignment achieved in a recently completed study (historical control) with conventional instrumentation.
Each enrolled Subject will undergo a total knee replacement using the TruMatch™ surgical technique. This investigation will require the Subject to be followed once postoperatively to collect radiographs. Follow-up will occur typically 2 to 12 weeks after surgery and when the Subject can achieve full leg extension (+/-5 degrees) and can tolerate weight-bearing.
- Conditions
- Osteoarthritis, Knee
- Being tested
- TruMatch™ Personalized Solutions, Total Knee Arthroplasty with Conventional Instrumentation.
- 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.
TruMatch™ Personalized SolutionsOther
TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. 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.
Total Knee Arthroplasty with Conventional Instrumentation.Device
Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
| Study group | Role | What they receive |
|---|---|---|
| TruMatch™ Personalized Solutions | Other | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions Receives: Other: TruMatch™ Personalized Solutions |
| Historical Control | Other | Total Knee Arthroplasty (PFC Sigma System) implanted using conventional and CAS surgical techniques without TruMatch™ instrumentation. Receives: Device: Total Knee Arthroplasty with Conventional Instrumentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films
Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.
Measured: 12 weeks postoperatively (when subject has reached full knee extension)
Secondary outcomes (5)
Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes
Intraoperative (skin to skin) time was measured to the nearest minute. TruMatch personalized Solutions and Conventional instrumentation outcomes are provided
Measured: During the Procedure
Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments
Intraoperative Tourniquet time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes are provided
Measured: During the Procedure
Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments
Intraoperative Tourniquet to 1st Bone Cut time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes provided
Measured: During the Procedure
Coronal Alignment Femoral and Tibial
Femoral Component to mechanical axis (degrees) and Tibial component to mechanical axis (degrees)
Measured: 3-months
Sagittal Component Alignment
Sagittal Component Alignment analyzed and reported at 3- months
Measured: Collected at Pre-Op, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study start1 Oct 2009
- Primary completion1 Mar 2011
- Study completion1 Mar 2011
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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saleem Himden, BA, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108237
- Sponsor's protocol ID
- 08003
- Status last verified
- Oct 2023
- First submitted
- 1 Apr 2010
- Last updated
- 24 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of In Vivo Alignment With TruMatch™ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKR)
- ClinicalTrials.gov ID
- NCT01108237
- Acronym / sponsor ID
- 08003
- 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
- 78 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 1 Mar 2011 (actual)
- Study completion
- 1 Mar 2011 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Posted 21 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventional surgical techniques.
The purpose of this investigation is to determine whether TruMatch™ alignment is non-inferior to alignment achieved with conventional instrumentation. This investigation will compare long leg alignment in total knee replacement achieved by the two types of procedures. Radiographic analysis will be performed by the same independent radiographic reviewer as the historical control study.
Detailed description
The study is designed as a prospective, multi-center, non-randomized, clinical investigation to determine whether TruMatch™ alignment is non-inferior to alignment achieved in a recently completed study (historical control) with conventional instrumentation.
Each enrolled Subject will undergo a total knee replacement using the TruMatch™ surgical technique. This investigation will require the Subject to be followed once postoperatively to collect radiographs. Follow-up will occur typically 2 to 12 weeks after surgery and when the Subject can achieve full leg extension (+/-5 degrees) and can tolerate weight-bearing.
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 | Other | Other: TruMatch™ Personalized SolutionsCruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions |
| Historical Control | Other | Device: Total Knee Arthroplasty with Conventional Instrumentation.Total Knee Arthroplasty (PFC Sigma System) implanted using conventional and CAS surgical techniques without TruMatch™ instrumentation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects meeting all of the following specific criteria will be considered for participation in the study:
- 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 has given consent to the transfer of his/her information to DePuy.
Key exclusion criteria (12 listed)
- Subjects will be excluded from participation in the trial if they meet any of the following criteria:
- The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
- The Subject is a woman who is pregnant or lactating.
- The Subject is a known drug or alcohol abuser or has a psychological disorder that could affect follow-up care or treatment outcomes.
- The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
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 |
|---|---|---|
| TruMatch™ Personalized SolutionsTruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. 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 |
| Total Knee Arthroplasty with Conventional Instrumentation.Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation. | Device | Historical Control |
Primary outcome
Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films
Time frame: 12 weeks postoperatively (when subject has reached full knee extension)
Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.
5 secondary outcomes
Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes
Time frame: During the Procedure
Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments
Time frame: During the Procedure
Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments
Time frame: During the Procedure
Coronal Alignment Femoral and Tibial
Time frame: 3-months
Sagittal Component Alignment
Time frame: Collected at Pre-Op, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- 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.
Saleem Himden, BA 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 TruMatch™ Personalized Solutions and Total Knee Arthroplasty with Conventional Instrumentation. in people with Osteoarthritis, Knee, 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 12 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 24 Oct 2023. 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?
Yes. Results are posted in the registry (first posted 21 May 2012). 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?
Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films (time frame: 12 weeks postoperatively (when subject has reached full knee extension)). 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 24 Oct 2023.