Knee OsteoarthritisMIKRONCT00633113
Minimally Invasive Knee Replacement Outcomes (MIKRO) Study
A study testing MPPA and SV in people with Knee Osteoarthritis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally invasive knee joint replacement surgical techniques. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- MPPA and SV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Sep 2012
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of severely symptomatic knee osteoarthritis that has failed non- operative treatment
- Males and non-pregnant females, 35-85 years of age at the time of surgery
- ASA class 1 or 2
- Procedure will not require computer navigation
- Patient/Surgeon has not requested another implant
- Patient has signed an IRB approved study consent form
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- Patient is able and willing to actively participate in post-operative rehabilitation program
- Patient understands study requirements
- Patient is willing to comply with follow-up visits and diary documentations
- Patient is capable of independent ambulation
Who cannot join
- Skeletal immaturity
- More than 10 degrees of valgus or varus deformity as measured from a weight bearing AP alignment view
- Patients with bilateral knee osteoarthritis who are considering a simultaneous bilateral procedure
- Bone or ligament insufficiency that requires the use of augments or stems, or constrained component
- Daily pre-operative use of narcotic pain medication
- Prior knee arthroplasty
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- Patient is a prisoner
- Patient has had prior tibial tubercle osteotomy
- Patient's surgical knee would require removal of hardware prior to TKA
- Patient has < 95 degrees flexion pre-operatively
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques
The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally invasive knee joint replacement surgical techniques. The primary study hypothesis is that in comparing total knee replacement performed with the two different surgical techniques that respect four minimally invasive surgery principles (low-profile instrumentation, "minimally invasive" incision, overall minimal knee surgical intervention), a faster return to function will result when the technique does not incise the tendon.
Read the detailed description
This study does not include financial compensation for treatments involved.
- Conditions
- Knee Osteoarthritis
- Being tested
- MPPA, SV
- Keywords
- Total Knee Arthroplasty, Minimally Invasive Knee Replacement, Knee Osteoarthritis, Cost effectiveness minimally invasive knee surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPPAProcedure or surgery
- Medial Parapatellar Arthrotomy
SVProcedure or surgery
- Subvastus Technique
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | - Medial Parapatellar Arthrotomy (MPPA) technique Receives: Procedure: MPPA |
| 2 | Active comparator | - Subvastus (SV) technique Receives: Procedure: SV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score.
Measured: 5 years
Secondary outcomes (1)
Secondary outcome: Includes cost-effectiveness of the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups; EQ-5D, SF-12; radiographic assessment using Knee Society Radiographic Assessment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Ivan M Tomek, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633113
- Sponsor's protocol ID
- MIKRO
- Acronym
- MIKRO
- Status last verified
- Apr 2013
- First submitted
- 4 Mar 2008
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques
- ClinicalTrials.gov ID
- NCT00633113
- Acronym / sponsor ID
- MIKRO / MIKRO
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Minimally Invasive Knee Replacement, Knee Osteoarthritis, Cost effectiveness minimally invasive knee surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Nov 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Mar 2008 (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 evaluate and compare the clinical, radiographic (x-ray) and cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally invasive knee joint replacement surgical techniques. The primary study hypothesis is that in comparing total knee replacement performed with the two different surgical techniques that respect four minimally invasive surgery principles (low-profile instrumentation, "minimally invasive" incision, overall minimal knee surgical intervention), a faster return to function will result when the technique does not incise the tendon.
Detailed description
This study does not include financial compensation for treatments involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: MPPA- Medial Parapatellar Arthrotomy (MPPA) technique |
| 2 | Active comparator | Procedure: SV- Subvastus (SV) technique |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Presence of severely symptomatic knee osteoarthritis that has failed non- operative treatment
- Males and non-pregnant females, 35-85 years of age at the time of surgery
- ASA class 1 or 2
- Procedure will not require computer navigation
- Patient/Surgeon has not requested another implant
Key exclusion criteria (10 listed)
- Skeletal immaturity
- More than 10 degrees of valgus or varus deformity as measured from a weight bearing AP alignment view
- Patients with bilateral knee osteoarthritis who are considering a simultaneous bilateral procedure
- Bone or ligament insufficiency that requires the use of augments or stems, or constrained component
- Daily pre-operative use of narcotic pain medication
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 |
|---|---|---|
| MPPA- Medial Parapatellar Arthrotomy | Procedure or surgery | 1 |
| SV- Subvastus Technique | Procedure or surgery | 2 |
Primary outcome
Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score.
Time frame: 5 years
1 secondary outcome
Secondary outcome: Includes cost-effectiveness of the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups; EQ-5D, SF-12; radiographic assessment using Knee Society Radiographic Assessment.
Time frame: 5 years
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 29 Apr 2013.
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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.
Ivan M Tomek, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPPA and SV in people with Knee Osteoarthritis, run by Dartmouth-Hitchcock Medical Center 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?
The sponsor lists 10 inclusion and 10 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 29 Apr 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.
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?
Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score. (time frame: 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 29 Apr 2013.