Osteoarthritis, KneePhase 4MISNCT02625311
Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty
A Phase 4 study testing surgery method using CR TKP in people with Osteoarthritis, Knee, run by Maastricht University Medical Center.
Trial summary
Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis. Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- surgery method using CR TKP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Jan 2015
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient requiring Total Knee Arthroplasty (TKA)
- patients with Osteo arthritis
- intact collateral ligaments and patella tendon
- patients willing and able to comply with the post-operative schedule
Who cannot join
- patients who require a revision TKA
- patients with TKA contralateral knee within 6 months with bad outcomes
- patients who need a TKA on contralateral side within 2 years
- intraoperative resurfacing of patella
- intraoperative eversion of patella
- patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy
Show all 15Show fewer
- BMI > 30
- patients with fixed flexion contracture> 15 degrees
- patients with deformity greater than 20 degrees of varus or 15 degrees of valgus
- Patient with Mediolateral stability > 10 degrees patient with active or suspected malignancy
- patient with Rheumatoid arthritis
- patient with systemic disease that would effect subject's wellfare or overall outcome of the study
- patient with other severe concurrent joint involvement which can effect their outcome
- patients with an immobile hip
- patient with a history of Pulmonary embolism or Deep venous thrombosis
About this study
Official title: A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty
Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis.
Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.
Read the detailed description
Study executed with 3 centers and 69 patients.
- Conditions
- Osteoarthritis, Knee
- Being tested
- surgery method using CR TKP
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery method using CR TKPProcedure or surgery
Also called Cruciate retaining (CR total knee prosthesis (TKP) Stryker
Operation through minimal invasive surgery or standard open surgery
| Study group | Role | What they receive |
|---|---|---|
| MIS | Experimental | Minimal invasive surgery for placement total knee prosthesis Receives: Procedure: surgery method using CR TKP |
| conventional approach | Active comparator | conventional "open" surgery for placement total knee prosthesis. Receives: Procedure: surgery method using CR TKP |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
measurement of flexion and extension in degrees
Measured: pre-op vs post-op until 5 years post-op
blood loss
measurement of milliliters blood loss during the first 24 hours after surgery
Measured: 24 hours after surgery
Secondary outcomes (2)
patient questionnaire
WOMAC pain and function score
Measured: pre-op vs post-op until 5 year post operative
chair rise and stair climb test
Ability of patient rise from chair and climb stairs, amount of pain on VAS 1-10 does the patient have during these activities
Measured: pre-op vs post-op until 5 years post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startDec 2004
- Primary completionFeb 2011
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625311
- Sponsor's protocol ID
- MEC04-105
- Acronym
- MIS
- Status last verified
- Nov 2015
- First submitted
- 30 Nov 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Feczko P, Engelmann L, Arts JJ, Campbell D. Computer-assisted total knee arthroplasty using mini midvastus or medial parapatellar approach technique: A prospective, randomized, international multicentre trial. BMC Musculoskelet Disord. 2016 Jan 13;17:19. doi: 10.1186/s12891-016-0872-7.
PubMed 26762175
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02625311
- Acronym / sponsor ID
- MIS / MEC04-105
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Dec 2015 (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.
Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis.
Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.
Detailed description
Study executed with 3 centers and 69 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIS | Experimental | Procedure: surgery method using CR TKPMinimal invasive surgery for placement total knee prosthesis |
| conventional approach | Active comparator | Procedure: surgery method using CR TKPconventional "open" surgery for placement total knee prosthesis. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient requiring Total Knee Arthroplasty (TKA)
- patients with Osteo arthritis
- intact collateral ligaments and patella tendon
- patients willing and able to comply with the post-operative schedule
Key exclusion criteria (15 listed)
- patients who require a revision TKA
- patients with TKA contralateral knee within 6 months with bad outcomes
- patients who need a TKA on contralateral side within 2 years
- intraoperative resurfacing of patella
- intraoperative eversion of patella
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 |
|---|---|---|
| surgery method using CR TKPAlso: Cruciate retaining (CR total knee prosthesis (TKP) StrykerOperation through minimal invasive surgery or standard open surgery | Procedure or surgery | MIS, conventional approach |
Primary outcome
range of motion
Time frame: pre-op vs post-op until 5 years post-op
measurement of flexion and extension in degrees
blood loss
Time frame: 24 hours after surgery
measurement of milliliters blood loss during the first 24 hours after surgery
2 secondary outcomes
patient questionnaire
Time frame: pre-op vs post-op until 5 year post operative
chair rise and stair climb test
Time frame: pre-op vs post-op until 5 years post operative
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 9 Dec 2015.
- Derived from this study: PubMed 26762175Feczko P, Engelmann L, Arts JJ, Campbell D. Computer-assisted total knee arthroplasty using mini midvastus or medial parapatellar approach technique: A prospective, randomized, international multicentre trial. BMC Musculoskelet Disord. 2016 Jan 13;17:19. doi: 10.1186/s12891-016-0872-7.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing surgery method using CR TKP in people with Osteoarthritis, Knee, run by Maastricht University Medical Center.
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 15 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 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
range of motion (time frame: pre-op vs post-op until 5 years post-op). The study lists 2 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 NCT02625311, which also lists 1 linked publication.
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 9 Dec 2015.