Knee ArthritisPhase 3NCT01242085
Preoperative Alignment of Total Knee Replacement
A Phase 3 study testing trumatch group in people with Knee Arthritis, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- trumatch group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jan 2013
- Phase
- Phase 3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:patients undergoing primary total knee replacement -
Exclusion Criteria:patients who have hardware involving the hip, knee or ankle
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alignment of Total Knee Components Using Standard or Custom Instrumentation
The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.
Read the detailed description
Patients will be randomized to have either customized knee instruments or standard generic instrumentation for primary total knee replacement. Postoperative CT scan will be used to determine alignment of each group.
- Conditions
- Knee Arthritis
- Being tested
- trumatch group, control group
- Keywords
- alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trumatch groupProcedure or surgery
Also called trumatch CPI
these patient will have CT based customized knee instruments used for surgery
control groupProcedure or surgery
Also called Depuy knee instruments
these patients will have standard instrumentation used for for knee replacement
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | control group will have standard instrumentation of their knee replacement Receives: Procedure: control group |
| trumatch group | Experimental | the trumatch patient will have custom instruments made from preop CT scans Receives: Procedure: trumatch group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment of Knee - Measured Mechanical Axis From CT Data
the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment
Measured: postoperatively - CT done within 1 week of surgery
Secondary outcomes (1)
Surgical Time
the difference between the average surgical time will be determined and compared with 95% CI
Measured: intraoperative surgical time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2012
- Study completionJan 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 Knee ArthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Principal investigator, steven woolson, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242085
- Sponsor's protocol ID
- 04061991
- Status last verified
- May 2013
- First submitted
- 15 Nov 2010
- Last updated
- 14 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alignment of Total Knee Components Using Standard or Custom Instrumentation
- ClinicalTrials.gov ID
- NCT01242085
- Acronym / sponsor ID
- 04061991
- Conditions
- Knee Arthritis
- Keywords
- alignment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- DePuy Orthopaedics
- Study start
- Nov 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Posted 8 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.
Detailed description
Patients will be randomized to have either customized knee instruments or standard generic instrumentation for primary total knee replacement. Postoperative CT scan will be used to determine alignment of each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: control groupcontrol group will have standard instrumentation of their knee replacement |
| trumatch group | Experimental | Procedure: trumatch groupthe trumatch patient will have custom instruments made from preop CT scans |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 groupAlso: trumatch CPIthese patient will have CT based customized knee instruments used for surgery | Procedure or surgery | trumatch group |
| control groupAlso: Depuy knee instrumentsthese patients will have standard instrumentation used for for knee replacement | Procedure or surgery | control group |
Primary outcome
Alignment of Knee - Measured Mechanical Axis From CT Data
Time frame: postoperatively - CT done within 1 week of surgery
the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment
1 secondary outcome
Surgical Time
Time frame: intraoperative surgical time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trumatch group in people with Knee Arthritis, run by VA Palo Alto Health Care System at 1 site 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?
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 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 May 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?
Alignment of Knee - Measured Mechanical Axis From CT Data (time frame: postoperatively - CT done within 1 week of surgery). 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 14 May 2013; AzTrials last refreshed its copy on 31 Oct 2026.