Knee ArthritisNCT00862316
Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit
A study testing Oxford Unicompartmental Knee in people with Knee Arthritis, run by Zimmer Biomet at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether a computer navigational unit can improve operating time and consistency during Knee arthroplasty when compared to knee arthroplasty without a computer navigational unit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- Oxford Unicompartmental Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to May 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- symptomatic unicompartmental knee arthritis major surgery
- failed non operative treatment modalities
- willing and able to give informed consent
- skeletal maturity
Who cannot join
- medical conditions that preclude general or spinal anesthetic
- ipsilateral knee avascular necrosis
- severe osteoporosis or osteopenia
- neuromuscular impairment
- ipsilateral knee infection
- Patient day surgery criteria
Show all 12Show fewer
- medically stable: an ASA category of 1 or 2
- close proximity to the hospital surgery performed for at least 36 hours
- good support system in place- someone able to stay with the patient for at least 36 hours immediately post-op.
- hemovac to be removed prior to discharge
- access to VON or other home care hospital approved services
- pain buster for pain control for 24 to 36 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome Analysis of the Oxford Unicompartmental Knee Arthroplasty With and Without the Assistance of a Computer Navigational Unit
The purpose of this study is to determine whether a computer navigational unit can improve operating time and consistency during Knee arthroplasty when compared to knee arthroplasty without a computer navigational unit.
Read the detailed description
The ability to use a computerized navigational unit during knee arthroplasty can be a major benefit to surgeons that perform a small amount of knee arthroplasties. Navigational assistance can decrease surgery and anesthesia time as well as decreasing variation in posterior tibial slope and improved range of motion.
- Conditions
- Knee Arthritis
- Being tested
- Oxford Unicompartmental Knee
- Keywords
- Eligible for Unicompartmental Knee Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford Unicompartmental KneeDevice
Knee Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Computer Navigational Unit Assistance | Experimental | Oxford Unicompartmental Knee arthroplasty will be performed with the assistance of a computer navigational unit. Receives: Device: Oxford Unicompartmental Knee |
| Non- Computer Navigational Unit Assisted | Active comparator | Oxford Unicompartmental Knee arthroplasty will be performed traditionally (without the assistance of a computer navigational unit). Receives: Device: Oxford Unicompartmental Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative record
Measured: Immediately Post-Op
Visual Analogue for pain, activity, and patient satisfaction (VAS)
Measured: 1 year
American Knee Society Score (AKSS)
Measured: 1 year
Secondary outcomes (5)
Oxford Knee 12
Measured: 1 year
Western Ontario MacMaster(WOMAC)
Measured: 1 year
SF 12
Measured: 1 year
Gait Belt Analysis
Measured: 1 year
Radiographic Output
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dartmouth General Hospital
- Responsible party
- Sponsor
- Investigators
- Vikram Venugopal, Dr., Principal investigator, Dartmouth General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862316
- Sponsor's protocol ID
- CA4
- Status last verified
- Jun 2017
- First submitted
- 3 Feb 2009
- Last updated
- 16 Jun 2017
- Results posted
- No
Publications
Svard UC, Price AJ. Oxford medial unicompartmental knee arthroplasty. A survival analysis of an independent series. J Bone Joint Surg Br. 2001 Mar;83(2):191-4. doi: 10.1302/0301-620x.83b2.10966.
PubMed 11284563Murray DW, Goodfellow JW, O'Connor JJ. The Oxford medial unicompartmental arthroplasty: a ten-year survival study. J Bone Joint Surg Br. 1998 Nov;80(6):983-9. doi: 10.1302/0301-620x.80b6.8177.
PubMed 9853489Price AJ, Webb J, Topf H, Dodd CA, Goodfellow JW, Murray DW; Oxford Hip and Knee Group. Rapid recovery after oxford unicompartmental arthroplasty through a short incision. J Arthroplasty. 2001 Dec;16(8):970-6. doi: 10.1054/arth.2001.25552.
PubMed 11740750Kreibich DN, Vaz M, Bourne RB, Rorabeck CH, Kim P, Hardie R, Kramer J, Kirkley A. What is the best way of assessing outcome after total knee replacement? Clin Orthop Relat Res. 1996 Oct;(331):221-5. doi: 10.1097/00003086-199610000-00031.
PubMed 8895642
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Analysis of the Oxford Unicompartmental Knee Arthroplasty With and Without the Assistance of a Computer Navigational Unit
- ClinicalTrials.gov ID
- NCT00862316
- Acronym / sponsor ID
- CA4
- Conditions
- Knee Arthritis
- Keywords
- Eligible for Unicompartmental Knee Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Dartmouth General Hospital
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Mar 2009 (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 this study is to determine whether a computer navigational unit can improve operating time and consistency during Knee arthroplasty when compared to knee arthroplasty without a computer navigational unit.
Detailed description
The ability to use a computerized navigational unit during knee arthroplasty can be a major benefit to surgeons that perform a small amount of knee arthroplasties. Navigational assistance can decrease surgery and anesthesia time as well as decreasing variation in posterior tibial slope and improved range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer Navigational Unit Assistance | Experimental | Device: Oxford Unicompartmental KneeOxford Unicompartmental Knee arthroplasty will be performed with the assistance of a computer navigational unit. |
| Non- Computer Navigational Unit Assisted | Active comparator | Device: Oxford Unicompartmental KneeOxford Unicompartmental Knee arthroplasty will be performed traditionally (without the assistance of a computer navigational unit). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- symptomatic unicompartmental knee arthritis major surgery
- failed non operative treatment modalities
- willing and able to give informed consent
- skeletal maturity
Key exclusion criteria (12 listed)
- medical conditions that preclude general or spinal anesthetic
- ipsilateral knee avascular necrosis
- severe osteoporosis or osteopenia
- neuromuscular impairment
- ipsilateral knee infection
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 |
|---|---|---|
| Oxford Unicompartmental KneeKnee Arthroplasty | Device | Computer Navigational Unit Assistance, Non- Computer Navigational Unit Assisted |
Primary outcome
Operative record
Time frame: Immediately Post-Op
Visual Analogue for pain, activity, and patient satisfaction (VAS)
Time frame: 1 year
American Knee Society Score (AKSS)
Time frame: 1 year
5 secondary outcomes
Oxford Knee 12
Time frame: 1 year
Western Ontario MacMaster(WOMAC)
Time frame: 1 year
SF 12
Time frame: 1 year
Gait Belt Analysis
Time frame: 1 year
Radiographic Output
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Background: PubMed 11284563Svard UC, Price AJ. Oxford medial unicompartmental knee arthroplasty. A survival analysis of an independent series. J Bone Joint Surg Br. 2001 Mar;83(2):191-4. doi: 10.1302/0301-620x.83b2.10966.
- Background: PubMed 9853489Murray DW, Goodfellow JW, O'Connor JJ. The Oxford medial unicompartmental arthroplasty: a ten-year survival study. J Bone Joint Surg Br. 1998 Nov;80(6):983-9. doi: 10.1302/0301-620x.80b6.8177.
- Background: PubMed 11740750Price AJ, Webb J, Topf H, Dodd CA, Goodfellow JW, Murray DW; Oxford Hip and Knee Group. Rapid recovery after oxford unicompartmental arthroplasty through a short incision. J Arthroplasty. 2001 Dec;16(8):970-6. doi: 10.1054/arth.2001.25552.
- Background: PubMed 8895642Kreibich DN, Vaz M, Bourne RB, Rorabeck CH, Kim P, Hardie R, Kramer J, Kirkley A. What is the best way of assessing outcome after total knee replacement? Clin Orthop Relat Res. 1996 Oct;(331):221-5. doi: 10.1097/00003086-199610000-00031.
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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.
Vikram Venugopal, Dr. principal investigator
Dartmouth General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxford Unicompartmental Knee in people with Knee Arthritis, run by Zimmer Biomet at 1 site in Canada.
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 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 16 Jun 2017. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Operative record (time frame: Immediately Post-Op). 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 NCT00862316, which also lists 4 linked publications.
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 16 Jun 2017.