OsteoarthritisPhase 2NCT01576445
Functional Outcome in Two Types of Total Knee Replacement Surgery for People With Osteoarthritis
A Phase 2 study testing Mid-vastus approach and medial parapatellar approach in people with Osteoarthritis, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
When performing total knee replacement surgery, the surgeon has a choice as to which type of surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the so-called 'medial parapatellar' exposure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Mid-vastus approach and medial parapatellar approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Feb 2012
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total knee arthroplasty
- Osteoarthritis
- Surgery at Royal Infirmary Edinburgh by participating surgeons
Who cannot join
- A Body Mass Index of more than 40
- Fixed valgus deformity of more than 15 degrees
- Inflammatory polyarthritis
- disorders of the feet, ankles or hips or spine causing abnormal gait or significant pain
- dementia
- severe visual impairment
- neurological conditions affecting movement
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial to Compare the Speed of Recovery and Functional Outcome Following Total Knee Replacement (TKR) Using a Quadriceps Sparing Approach to the Knee Against a Standard Medial Parapatellar Surgical Exposure
When performing total knee replacement surgery, the surgeon has a choice as to which type of surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the so-called 'medial parapatellar' exposure. And alternative and more recently introduced technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the muscle at the front of the leg. In this study we compare the two surgical techniques in a so-called randomized trial. This means that we put people randomly into two groups, one group will receive surgery with the 'Mid-vastus approach' and the other group the surgery with the 'Medial parapatellar approach'. It is hypothesized that people who receive the Mid-vastus approach recover quicker and have a better short-term functional outcome than people who receive the 'Medial parapatellar approach'.
Read the detailed description
This study is a prospective randomized controlled double blind trial in which both immediate post-operative recovery and functional outcome at 6 weeks, 3 and 6 months after total knee replacement surgery will be assessed for two different types of surgical approach; Medial Parapatellar and Mid-vastus.
Functional outcome will be assessed by recording the kinematics of the lower limb joints in addition to muscle activity (electromyography) during walking, stair ascending and descending and getting up from a chair through computerized 3D motion analysis. Outcome measures will be recorded immediate post surgery and at medium follow-up and will cover all areas of the World Health Organisation, International Components of Functioning, Disability and Health (ICF) components 'Body Structures and Functions/Impairments' ,'Activities and Participation' and 'Personal factors'. It is hypothesized that by minimizing the damage to the quadriceps, patients operated using the Mid-vastus approach will have better muscle function and will therefore have more normal knee range of motion, knee joint loading and muscle activity patterns compared to those with the Medial Parapatellar approach.
- Conditions
- Osteoarthritis
- Being tested
- Mid-vastus approach, medial parapatellar approach
- Keywords
- Total Knee Arthroplasty, function
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid-vastus approachProcedure or surgery
Mid-vastus approach to avoid patellar eversion and to minimise the muscle split.
medial parapatellar approachProcedure or surgery
medial parapatellar approach
| Study group | Role | What they receive |
|---|---|---|
| Mid-vastus approach | Experimental | Not described Receives: Procedure: Mid-vastus approach |
| medial parapatellar approach | Experimental | Not described Receives: Procedure: medial parapatellar approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Functional knee range of motion from pre surgery to 6 months post surgery
The knee range of motion during functional activities such as walking and stair ascending and descending is recorded using three dimensional motion analysis
Measured: 6 months after surgery
Secondary outcomes (5)
change in WOMAC from pre surgery to 6 month after surgery
Western Ontario McMaster Universities (WOMAC) osteoarthris Index is patient-reported outcome and has three components: Pain, Stiffness and Function.
Measured: 6 months after surgery
Change in Timed up and Go test from pre-surgery to 6 month post surgery
Measured: 6 months after surgery
Change in range of motion of the knee in prone from pre surgery to post surgery
The range of motion of the knee is measured using a manual goniometer.
Measured: 6 months after surgery
Change in Objective daily physical activity from pre to 6 month post surgery
Objective daily physical activity is recorded using an activity monitor
Measured: 6 month post surgery
Change in knee extensor strength from pre surgery to 6 months after surgery
Knee extensor strength is measured using a digital myometer
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startMar 2010
- Primary completionJan 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy International, Royal Infirmary of Edinburgh
- Responsible party
- Principal investigator, Marietta van der Linden, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576445
- Sponsor's protocol ID
- MIS1
- Status last verified
- Apr 2012
- First submitted
- 10 Apr 2012
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Compare the Speed of Recovery and Functional Outcome Following Total Knee Replacement (TKR) Using a Quadriceps Sparing Approach to the Knee Against a Standard Medial Parapatellar Surgical Exposure
- ClinicalTrials.gov ID
- NCT01576445
- Acronym / sponsor ID
- MIS1
- Conditions
- Osteoarthritis
- Keywords
- Total Knee Arthroplasty, function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- DePuy International, Royal Infirmary of Edinburgh
- Study start
- Mar 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 12 Apr 2012 (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.
When performing total knee replacement surgery, the surgeon has a choice as to which type of surgical technique to use. The standard technique at the Royal Infirmary in Edinburgh is the so-called 'medial parapatellar' exposure. And alternative and more recently introduced technique is the 'Mid-vastus approach' in which the surgeon will cut through less of the muscle at the front of the leg. In this study we compare the two surgical techniques in a so-called randomized trial. This means that we put people randomly into two groups, one group will receive surgery with the 'Mid-vastus approach' and the other group the surgery with the 'Medial parapatellar approach'. It is hypothesized that people who receive the Mid-vastus approach recover quicker and have a better short-term functional outcome than people who receive the 'Medial parapatellar approach'.
Detailed description
This study is a prospective randomized controlled double blind trial in which both immediate post-operative recovery and functional outcome at 6 weeks, 3 and 6 months after total knee replacement surgery will be assessed for two different types of surgical approach; Medial Parapatellar and Mid-vastus.
Functional outcome will be assessed by recording the kinematics of the lower limb joints in addition to muscle activity (electromyography) during walking, stair ascending and descending and getting up from a chair through computerized 3D motion analysis. Outcome measures will be recorded immediate post surgery and at medium follow-up and will cover all areas of the World Health Organisation, International Components of Functioning, Disability and Health (ICF) components 'Body Structures and Functions/Impairments' ,'Activities and Participation' and 'Personal factors'. It is hypothesized that by minimizing the damage to the quadriceps, patients operated using the Mid-vastus approach will have better muscle function and will therefore have more normal knee range of motion, knee joint loading and muscle activity patterns compared to those with the Medial Parapatellar approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mid-vastus approach | Experimental | Procedure: Mid-vastus approach |
| medial parapatellar approach | Experimental | Procedure: medial parapatellar approach |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total knee arthroplasty
- Osteoarthritis
- Surgery at Royal Infirmary Edinburgh by participating surgeons
Key exclusion criteria (8 listed)
- A Body Mass Index of more than 40
- Fixed valgus deformity of more than 15 degrees
- Inflammatory polyarthritis
- disorders of the feet, ankles or hips or spine causing abnormal gait or significant pain
- dementia
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 |
|---|---|---|
| Mid-vastus approachMid-vastus approach to avoid patellar eversion and to minimise the muscle split. | Procedure or surgery | Mid-vastus approach |
| medial parapatellar approachmedial parapatellar approach | Procedure or surgery | medial parapatellar approach |
Primary outcome
change in Functional knee range of motion from pre surgery to 6 months post surgery
Time frame: 6 months after surgery
The knee range of motion during functional activities such as walking and stair ascending and descending is recorded using three dimensional motion analysis
5 secondary outcomes
change in WOMAC from pre surgery to 6 month after surgery
Time frame: 6 months after surgery
Change in Timed up and Go test from pre-surgery to 6 month post surgery
Time frame: 6 months after surgery
Change in range of motion of the knee in prone from pre surgery to post surgery
Time frame: 6 months after surgery
Change in Objective daily physical activity from pre to 6 month post surgery
Time frame: 6 month post surgery
Change in knee extensor strength from pre surgery to 6 months after surgery
Time frame: 6 months after surgery
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 12 Apr 2012.
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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 2 study testing Mid-vastus approach and medial parapatellar approach in people with Osteoarthritis, run by Queen Margaret University at 1 site in United Kingdom.
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 3 inclusion and 8 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 12 Apr 2012. 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 Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
change in Functional knee range of motion from pre surgery to 6 months post surgery (time frame: 6 months after 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 12 Apr 2012.