OsteoarthritisNCT01807494
Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches
A study testing Total hip replacement components in people with Osteoarthritis and Avascular Necrosis, run by New Lexington Clinic at 1 site in United States.
Trial summary
Hip replacement is a common surgical procedure performed to relieve the pain and disability. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the hip with metal and plastic components shaped to allow continued motion of the hip. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis
- What is being tested?
- Total hip replacement components
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between ages of 18 and 85
- End stage hip joint degeneration
- Has elected to undergo primary total hip arthroplasty
Who cannot join
- Undergoing revision arthroplasty
- Inflammatory or rheumatoid arthritis
- Patients with confounding medical conditions that are not expected to survive for the duration of follow-up (10 years)
- Body Mass Index greater than 40 kg/m2
- Age < 18 or > than 85
- Previous ipsilateral hip surgery including arthroscopic procedures
Trial locations and contacts
1 site in 1 country.
About this study
Hip replacement is a common surgical procedure performed to relieve the pain and disability. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons may perform this operation in several different ways. The purpose of this study is to compare two different methods of performing total hip replacement. The investigators hypothesize that subjects treated with the anterior approached may show improved function during the early postoperative period, but that no differences in pain or function will be present after the first postoperative year.
In this study, patients that have elected to have hip replacement and consented to participate in the study will be randomized to have his or her hip replaced using one of two surgical techniques. Subjects will be randomized to be implanted using either an anterior or posterior approach. With the anterior approach, the study surgeon will use an incision that is on the front of the hip, and with the posterior approach, the incision will be more on the backside of your hip. The study surgeon has done more than 300 total hip replacements with both of these techniques.
A baseline assessment will be conducted before hip replacement surgery that includes x-rays, functional tasks like getting up from a chair and stepping down a step, and three questionnaires about the hip, the subject's general health, and how well the subject is able to function. Also, subjects will be required to return to the clinic at several time points after surgery for follow-up visits. Follow-up visits will include hip assessments and questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3 months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These follow-up visits are part of the study surgeon's normal routine for hip replacement patients, and are not extra visits as a part of this study.
- Conditions
- Osteoarthritis, Avascular Necrosis
- Being tested
- Total hip replacement components
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacement componentsDevice
Also called Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+
All patients will receive the same implants
| Study group | Role | What they receive |
|---|---|---|
| Posterior approach | Active comparator | Subjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components. Receives: Device: Total hip replacement components |
| Anterior Approach | Active comparator | Subjects in this group will have total hip replacement performed with a direct anterior surgical approach and total hip replacement components. Receives: Device: Total hip replacement components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discontinued use of an assistive ambulatory device (cane or walker)
Measured: 6 week postoperative follow-up
Secondary outcomes (8)
modified Harris Hip Score
Measured: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
SF-12
Measured: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
Lower Extremity Functional Score
Measured: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
Functional force testing
Testing to objectively quantify subject function when rising from a chair and descending stairs
Measured: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
implant survivorship
Measured: 1-, 2-, 5-, 7-, and 10-year follow-ups
Length of hospital stay
Measured: Collected during the hospital stay (usually 1 to 5 days)
Operative time
Measured: Intra-operative
Number of patients that require blood transfusion
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Lexington Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Biomet Orthopedics, LLC
- Responsible party
- Sponsor
- Investigators
- Christian P Christensen, MD, Principal investigator, Lexington Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807494
- Sponsor's protocol ID
- LCO.2012.05
- Status last verified
- Oct 2015
- First submitted
- 4 Mar 2013
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Anterior Versus Posterior Total Hip Arthroplasty Surgical Approaches
- ClinicalTrials.gov ID
- NCT01807494
- Acronym / sponsor ID
- LCO.2012.05
- Conditions
- Osteoarthritis, Avascular Necrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- New Lexington ClinicUniversity, hospital or other
- Collaborators
- Biomet Orthopedics, LLC
- Study start
- Nov 2012
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 8 Mar 2013 (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.
Hip replacement is a common surgical procedure performed to relieve the pain and disability. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the hip with metal and plastic components shaped to allow continued motion of the hip. Surgeons may perform this operation in several different ways. The purpose of this study is to compare two different methods of performing total hip replacement. The investigators hypothesize that subjects treated with the anterior approached may show improved function during the early postoperative period, but that no differences in pain or function will be present after the first postoperative year.
In this study, patients that have elected to have hip replacement and consented to participate in the study will be randomized to have his or her hip replaced using one of two surgical techniques. Subjects will be randomized to be implanted using either an anterior or posterior approach. With the anterior approach, the study surgeon will use an incision that is on the front of the hip, and with the posterior approach, the incision will be more on the backside of your hip. The study surgeon has done more than 300 total hip replacements with both of these techniques.
A baseline assessment will be conducted before hip replacement surgery that includes x-rays, functional tasks like getting up from a chair and stepping down a step, and three questionnaires about the hip, the subject's general health, and how well the subject is able to function. Also, subjects will be required to return to the clinic at several time points after surgery for follow-up visits. Follow-up visits will include hip assessments and questionnaires, as well as follow-up hip x-rays. The follow-up visits will be 6 weeks, 3 months, 1 year, 2 years, 5 years, 7 years, and 10 years after hip replacement surgery. These follow-up visits are part of the study surgeon's normal routine for hip replacement patients, and are not extra visits as a part of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior approach | Active comparator | Device: Total hip replacement componentsSubjects in this group will total hip replacement performed with a posterior surgical approach and total hip replacement components. |
| Anterior Approach | Active comparator | Device: Total hip replacement componentsSubjects in this group will have total hip replacement performed with a direct anterior surgical approach and total hip replacement components. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between ages of 18 and 85
- End stage hip joint degeneration
- Has elected to undergo primary total hip arthroplasty
Key exclusion criteria (6 listed)
- Undergoing revision arthroplasty
- Inflammatory or rheumatoid arthritis
- Patients with confounding medical conditions that are not expected to survive for the duration of follow-up (10 years)
- Body Mass Index greater than 40 kg/m2
- Age < 18 or > than 85
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 |
|---|---|---|
| Total hip replacement componentsAlso: Femoral component will be the Biomet Taperloc Complete and the acetabular component will be the Biomet Ringloc+All patients will receive the same implants | Device | Anterior Approach, Posterior approach |
Primary outcome
Time to discontinued use of an assistive ambulatory device (cane or walker)
Time frame: 6 week postoperative follow-up
8 secondary outcomes
modified Harris Hip Score
Time frame: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
SF-12
Time frame: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
Lower Extremity Functional Score
Time frame: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
Functional force testing
Time frame: Preoperative (no more than 3 months before surgery), and at 6-week, 12-week, 1-, 2-, 5-, 7-, and 10-year follow-ups
implant survivorship
Time frame: 1-, 2-, 5-, 7-, and 10-year follow-ups
Length of hospital stay
Time frame: Collected during the hospital stay (usually 1 to 5 days)
Operative time
Time frame: Intra-operative
Number of patients that require blood transfusion
Time frame: Intra-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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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.
Christian P Christensen, MD principal investigator
Lexington Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip replacement components in people with Osteoarthritis and Avascular Necrosis, run by New Lexington Clinic at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 6 Oct 2015. 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 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?
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?
Time to discontinued use of an assistive ambulatory device (cane or walker) (time frame: 6 week postoperative follow-up). 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 6 Oct 2015.