OsteoarthritisNCT01106560
A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement
A study testing Minimally Invasive Anterior Approach and Standard postero-lateral approach in people with Osteoarthritis and Rheumatoid Arthritis, run by Medacta International SA at 1 site in United Kingdom.
Trial summary
This is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Minimally Invasive Anterior Approach and Standard postero-lateral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Dec 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18-75 years at time of surgery.
- Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip.
- Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
- Patients who signed the study consent form prior to surgery.
Who cannot join
- Pregnant women or women who plan to conceive in the future.
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
- Those already treated by with a Total Hip Replacement (THR) (i.e. requiring a revision hip replacement).
- Those with co-existent ipsilateral knee disease or back problems
- Muscle contracture around the hip joint
- Individuals who have undergone organ transplant.
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- Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- Individuals who have had a THR on the contra-lateral side within the 6 months.
- Individuals who have undergone a THR on the contralateral side and whose outcome is considered unsatisfactory or not good. An unsatisfactory or poor result is defined as achieving a total UCLA score (including activity) < 16 points.
- Individuals requiring bilateral hip replacement.
- Individuals whose body mass index (BMI; kg/m2) >35.
- Individuals with active or suspected infection or sepsis.
- Individuals with renal failure and/or renal insufficiency.
- Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Elective Orthopaedic Centre (EOC)
Epsom, KT18 7EG
About this study
Official title: A Single Centre Prospective Randomised Controlled Clinical Trial Comparing Total Hip Arthroplasty Performed Either Through a Posterior Approach or a Direct Anterior Approach
This is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Being tested
- Minimally Invasive Anterior Approach, Standard postero-lateral approach
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Anterior ApproachProcedure or surgery
Anterior minimally invasive surgery (AMIS)
Standard postero-lateral approachProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Anterior Approach Group | Active comparator | (AMIS) Receives: Procedure: Minimally Invasive Anterior Approach |
| Posterior Approach Group | Active comparator | (Posterior) Receives: Procedure: Standard postero-lateral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach
Measured: on average up to 6 weeks
Secondary outcomes (7)
Clinical assessment of patient using the Harris Hip Score
Measured: pre-op and 6 weeks, 6 months, 1 year after surgery
Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score
Measured: pre-op, 1 year post-op
Assessment of patient's level of activity using the UCLA score
Measured: pre-op and 6 weeks, 6 months, 1 year after surgery
Radiological evaluation to assess the fixation and stability of femoral and acetabular components
Measured: pre-op and 6 weeks, 6 months, 1 year after surgery
Strength Testing
Muscle strength will be assessed using the MIE digital myometer (from patient #50 to patient #100)
Measured: 6 weeks, 6 months and 1y after surgery
MRI evaluation
A MRI examination will be used to detect any damage in the hip musculature and tendons (from patient #50 to patient #100)
Measured: preop-1y after surgery
Assessment of gait kinematics
Comparison gait analysis Anterior vs Posterior groups at fixed time point (from patient #50 to patient # 100)
Measured: 6 weeks, 12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2015
- Study completionDec 2015
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.
- More trials run by Medacta International SAThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard E Field, PhD FRCS(Orth), Principal investigator, British Orthopaedic Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106560
- Sponsor's protocol ID
- P01.004.12 rev.01
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2010
- Last updated
- 12 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Prospective Randomised Controlled Clinical Trial Comparing Total Hip Arthroplasty Performed Either Through a Posterior Approach or a Direct Anterior Approach
- ClinicalTrials.gov ID
- NCT01106560
- Acronym / sponsor ID
- P01.004.12 rev.01
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Apr 2010 (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.
This is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Approach Group | Active comparator | Procedure: Minimally Invasive Anterior Approach(AMIS) |
| Posterior Approach Group | Active comparator | Procedure: Standard postero-lateral approach(Posterior) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged 18-75 years at time of surgery.
- Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip.
- Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
- Patients who signed the study consent form prior to surgery.
Key exclusion criteria (14 listed)
- Pregnant women or women who plan to conceive in the future.
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
- Those already treated by with a Total Hip Replacement (THR) (i.e. requiring a revision hip replacement).
- Those with co-existent ipsilateral knee disease or back problems
- Muscle contracture around the hip joint
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 |
|---|---|---|
| Minimally Invasive Anterior ApproachAnterior minimally invasive surgery (AMIS) | Procedure or surgery | Anterior Approach Group |
| Standard postero-lateral approach | Procedure or surgery | Posterior Approach Group |
Primary outcome
Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach
Time frame: on average up to 6 weeks
7 secondary outcomes
Clinical assessment of patient using the Harris Hip Score
Time frame: pre-op and 6 weeks, 6 months, 1 year after surgery
Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score
Time frame: pre-op, 1 year post-op
Assessment of patient's level of activity using the UCLA score
Time frame: pre-op and 6 weeks, 6 months, 1 year after surgery
Radiological evaluation to assess the fixation and stability of femoral and acetabular components
Time frame: pre-op and 6 weeks, 6 months, 1 year after surgery
Strength Testing
Time frame: 6 weeks, 6 months and 1y after surgery
MRI evaluation
Time frame: preop-1y after surgery
Assessment of gait kinematics
Time frame: 6 weeks, 12 weeks and 6 months
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 2016.
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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.
Richard E Field, PhD FRCS(Orth) principal investigator
British Orthopaedic Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Anterior Approach and Standard postero-lateral approach in people with Osteoarthritis and Rheumatoid Arthritis, run by Medacta International SA 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 4 inclusion and 14 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 2016. 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.
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?
Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach (time frame: on average up to 6 weeks). 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 2016.