Osteoarthritis of the KneePhase 4MIS GEN IINCT00853398
MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty
A Phase 4 study testing surgical technique in people with Osteoarthritis of the Knee, run by Smith & Nephew Orthopaedics AG at 1 site in Germany.
Trial summary
Overall study design: A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system. The study will collect efficacy, safety and socio-economical data over 2 years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- surgical technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Oct 2004to Dec 2007
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- require primary uni- or bilateral total knee arthroplasty; available for 2 year follow up; provide informed consent; is in stable health for cardio-pulmonary conditions.
Who cannot join
- inefficient femoral or tibial bone stock; BMI >35; fixed flexion deformity >15 degrees; knee flexion of <90 degrees; varus/valgus deformity >20 degrees; active local infection; conditions that would compromise the 2 years follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective (Non)-Randomized Controlled Multicenter Clinical Study Of the Genesis ii Total Knee System in Minimally Invasive Total Knee Arthroplasty
Overall study design:
A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system. The study will collect efficacy, safety and socio-economical data over 2 years. An additional 5 years follow-up interval is optional. The objectives (short-term follow-up) of the study are to:
Read more
- Assess whether the improvement in Pain and Range of motion per Knee Society scoring system and VAS score.
- Assess whether there are any differences between the surgical techniques as regards complication rate.
- Assess whether the hospital stay and the rehabilitation time (Straight leg raise, Active/passive ROM) of the patients differs between the two techniques.
- Assess the x-ray mechanical alignment between the two techniques.
Attempts will be made to assess whether the collected peri-operative data (including incision length, blood loss, wound appearance, hospital readmissions and operative time) differs between the two surgical techniques.
The primary objectives (mid-term follow-up) of the study are to:
- Improvement in Pain and Function per Knee Society Scoring system
- Number and Extent of Radiographic Lucencies >2mm
- Revision and knee-related adverse events
- Improvement in Quality-of-life via the VAS score
5 investigational sites will participate and enroll a total of approximately 250 patients over a 12 months period. Thus, each site will enroll 50 patients.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- surgical technique
- Keywords
- Primary Osteoarthritis of the knee.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical techniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Minimal Invasive Surgery, | Experimental | Not described Receives: Procedure: surgical technique |
| Standard Surgical Technique | Active comparator | Not described Receives: Procedure: surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements
Measured: 1 year
Secondary outcomes (1)
Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startOct 2004
- Primary completionOct 2007
- Study completionDec 2007
Why it stopped: The results obtained 1 year after surgery were clearly indicative of the outcome and the investigators decided to terminate follow-up at that point.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 4
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853398
- Sponsor's protocol ID
- MIS_GEN_II_6112003
- Acronym
- MIS GEN II
- Status last verified
- May 2014
- First submitted
- 27 Feb 2009
- Last updated
- 23 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective (Non)-Randomized Controlled Multicenter Clinical Study Of the Genesis ii Total Knee System in Minimally Invasive Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00853398
- Acronym / sponsor ID
- MIS GEN II / MIS_GEN_II_6112003
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Primary Osteoarthritis of the knee.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The results obtained 1 year after surgery were clearly indicative of the outcome and the investigators decided to terminate follow-up at that point.
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 2 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.
Overall study design:
A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system. The study will collect efficacy, safety and socio-economical data over 2 years. An additional 5 years follow-up interval is optional. The objectives (short-term follow-up) of the study are to:
- Assess whether the improvement in Pain and Range of motion per Knee Society scoring system and VAS score.
- Assess whether there are any differences between the surgical techniques as regards complication rate.
- Assess whether the hospital stay and the rehabilitation time (Straight leg raise, Active/passive ROM) of the patients differs between the two techniques.
- Assess the x-ray mechanical alignment between the two techniques.
Attempts will be made to assess whether the collected peri-operative data (including incision length, blood loss, wound appearance, hospital readmissions and operative time) differs between the two surgical techniques.
The primary objectives (mid-term follow-up) of the study are to:
- Improvement in Pain and Function per Knee Society Scoring system
- Number and Extent of Radiographic Lucencies >2mm
- Revision and knee-related adverse events
- Improvement in Quality-of-life via the VAS score
5 investigational sites will participate and enroll a total of approximately 250 patients over a 12 months period. Thus, each site will enroll 50 patients.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Invasive Surgery, | Experimental | Procedure: surgical technique |
| Standard Surgical Technique | Active comparator | Procedure: surgical technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- require primary uni- or bilateral total knee arthroplasty; available for 2 year follow up; provide informed consent; is in stable health for cardio-pulmonary conditions.
Key exclusion criteria (1 listed)
- inefficient femoral or tibial bone stock; BMI >35; fixed flexion deformity >15 degrees; knee flexion of <90 degrees; varus/valgus deformity >20 degrees; active local infection; conditions that would compromise the 2 years follow up.
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 |
|---|---|---|
| surgical technique | Procedure or surgery | Minimal Invasive Surgery,, Standard Surgical Technique |
Primary outcome
Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements
Time frame: 1 year
1 secondary outcome
Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The results obtained 1 year after surgery were clearly indicative of the outcome and the investigators decided to terminate follow-up at that point.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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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 4 study testing surgical technique in people with Osteoarthritis of the Knee, run by Smith & Nephew Orthopaedics AG at 1 site in Germany.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 23 May 2014. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The results obtained 1 year after surgery were clearly indicative of the outcome and the investigators decided to terminate follow-up at that point.). Results are not available in the source record.
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?
Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements (time frame: 1 year). 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 23 May 2014.