OsteoarthritisNCT00951951
Gait Analysis of Anterior Versus Posterior Approach in Performance of Total Hip Arthroplasty
A study testing Anterior Approach and Posterior Approach in people with Osteoarthritis, run by Medacta USA at 4 sites in United States.
Trial summary
The primary objectives of the study is to compare gait kinematics and the return to normalization of gait in patients that have undergone a Total Hip Arthroplasty (THA) via the direct anterior approach versus the posterior approach. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Anterior Approach and Posterior Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2009to Dec 2014
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling the standard criteria for the implantation of primary total hip arthroplasty
- Those presenting with primary or secondary osteoarthritis
- Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use)
Who cannot join
- Pregnant women or women who plan to conceive within the year following surgery
- Inflammatory arthritic condition
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
- Those already treated with a failed Total Hip Arthroplasty (THA)
- Muscle contracture around the hip joint
- Individuals who have undergone organ transplant
Show all 16Show fewer
- Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
- Individuals who have had a THA on the contra-lateral side within the 6 months.
- Individuals who have undergone a THR on the contra-lateral side and whose outcome is considered unsatisfactory or not good
- Individuals requiring bilateral hip replacement
- Individuals whose body mass index (BMI; kg/m2) >40
- Individuals with active or suspected infection or sepsis
- Individuals with chronic renal failure as defined by the need for dialysis
- Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV
- History of drug and/or substance abuse
Trial locations and contacts
4 sites in 1 country.
United States4 sites
D. Kevin Lester, MD
Fresno, California, 93710
Peak Orthopedics
Lone Tree, Colorado, 80124
Intermountain Healthcare
St. George, Utah, 84790
Sun Valley Orthopedic Surgeons
Surprise, Arizona, 85374
About this study
Official title: Gait Analysis of Anterior vs. Posterior Approach in Performance of Total Hip Arthroplasty: A Multi-Centre, Prospective Trial
The primary objectives of the study is to compare gait kinematics and the return to normalization of gait in patients that have undergone a Total Hip Arthroplasty (THA) via the direct anterior approach versus the posterior approach. Gait kinematics will be measured using the IDEEA LifeGait device from Minisun (Fresno, CA).
Read the detailed description
This is a prospective study of two different surgical approaches to THA, direct anterior vs posterior approach in approximately 64 patients that meet the standard criteria for the implantation of primary total hip replacement utilizing the Medacta implants and have elected to undergo THA.
- Conditions
- Osteoarthritis
- Being tested
- Anterior Approach, Posterior Approach
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior ApproachProcedure or surgery
Anterior Minimal Invasive Surgery (AMIS)
Posterior ApproachProcedure or surgery
Also called Posterior Surgical Approach
| Study group | Role | What they receive |
|---|---|---|
| Anterior Surgical Approach | Active comparator | (AMIS) Receives: Procedure: Anterior Approach |
| Posterior Approach Group | Active comparator | Posterior surgical approach for total hip replacement. Receives: Procedure: Posterior 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: Pre-Op, (2 weeks if fully ambulatory), 6 weeks, 3 months, 1 year
Secondary outcomes (1)
Evaluate/compare two surgical approaches (direct anterior vs. posterior): Patient improvement (subjective and objective) following THA using the HHS. Patient overall function and pain following THA using the WOMAC. Post operative radiological findings
Measured: Pre-Op, 6 weeks, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2013
- Study completionDec 2014
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medacta International SA
- Responsible party
- Sponsor
- Investigators
- Tyler Goldberg, MD, Study director, Medacta USA Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951951
- Sponsor's protocol ID
- P0001
- Status last verified
- May 2022
- First submitted
- 31 Jul 2009
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis of Anterior vs. Posterior Approach in Performance of Total Hip Arthroplasty: A Multi-Centre, Prospective Trial
- ClinicalTrials.gov ID
- NCT00951951
- Acronym / sponsor ID
- P0001
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Collaborators
- Medacta International SA
- Study start
- Jun 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Aug 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.
The primary objectives of the study is to compare gait kinematics and the return to normalization of gait in patients that have undergone a Total Hip Arthroplasty (THA) via the direct anterior approach versus the posterior approach. Gait kinematics will be measured using the IDEEA LifeGait device from Minisun (Fresno, CA).
Detailed description
This is a prospective study of two different surgical approaches to THA, direct anterior vs posterior approach in approximately 64 patients that meet the standard criteria for the implantation of primary total hip replacement utilizing the Medacta implants and have elected to undergo THA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Surgical Approach | Active comparator | Procedure: Anterior Approach(AMIS) |
| Posterior Approach Group | Active comparator | Procedure: Posterior ApproachPosterior surgical approach for total hip replacement. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients fulfilling the standard criteria for the implantation of primary total hip arthroplasty
- Those presenting with primary or secondary osteoarthritis
- Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use)
Key exclusion criteria (16 listed)
- Pregnant women or women who plan to conceive within the year following surgery
- Inflammatory arthritic condition
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
- Those already treated with a failed Total Hip Arthroplasty (THA)
- 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 |
|---|---|---|
| Anterior ApproachAnterior Minimal Invasive Surgery (AMIS) | Procedure or surgery | Anterior Surgical Approach |
| Posterior ApproachAlso: Posterior Surgical 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: Pre-Op, (2 weeks if fully ambulatory), 6 weeks, 3 months, 1 year
1 secondary outcome
Evaluate/compare two surgical approaches (direct anterior vs. posterior): Patient improvement (subjective and objective) following THA using the HHS. Patient overall function and pain following THA using the WOMAC. Post operative radiological findings
Time frame: Pre-Op, 6 weeks, 3 months, 1 year
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 19 May 2022.
- Related InfoLink provided by the sponsor.
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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.
Tyler Goldberg, MD study director
Medacta USA Medical Director
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Approach and Posterior Approach in people with Osteoarthritis, run by Medacta USA at 4 sites 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 3 inclusion and 16 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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: Pre-Op, (2 weeks if fully ambulatory), 6 weeks, 3 months, 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 19 May 2022.