Total Hip ReplacementNCT01613508
A Randomized Study of Approaches in Total Hip Arthroplasty
A study testing Direct Anterior Approach and Mini-Posterior Approach in people with Total Hip Replacement, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary aim of the study is to compare the results of an established, successful procedure, which is total hip arthroplasty through a mini-posterior approach to a less studied - increasingly popular procedure, which is total hip replacement through the direct anterior approach utilizing the orthopedic table. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Direct Anterior Approach and Mini-Posterior Approach
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 27 Feb 2018
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female patients between 20 and 100 with unilateral osteoarthritis (DJD) who are surgical candidates for total hip arthroplasty
- Study participants must be able to give informed consent.
Who cannot join
- Significant proximal femoral deformity (post SCFE, Perthes, DDH), acetabular dysplasia (ANY CROWE), inflammatory arthritis, septic arthritis, osteomyelitis, prior infection of hip joint, significant leg length discrepancy (> 4cm), osteoporosis, arthrodesis of the affected hip.
- The presence of infections, highly communicable diseases, e.g. AIDS, active tuberculosis, venereal disease, hepatitis.
- Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
- Presence of previous prosthetic hip replacement device (any type).
- Active Metastatic disease
- Active major Psychiatric illness
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- Active Drug or alcohol abuse
- BMI > 40.
- Patients that are known to be pregnant
- Actively failing contralateral hip replacement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Clinical Trial of Direct Anterior Approach and Mini-Posterior Approach Total Hip Arthroplasty
The primary aim of the study is to compare the results of an established, successful procedure, which is total hip arthroplasty through a mini-posterior approach to a less studied - increasingly popular procedure, which is total hip replacement through the direct anterior approach utilizing the orthopedic table.
- Conditions
- Total Hip Replacement
- Being tested
- Direct Anterior Approach, Mini-Posterior Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Anterior ApproachProcedure or surgery
Mini-Posterior ApproachProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Direct Anterior Approach | Active comparator | An oblique incision is made over the anterior margin of the tensor muscle. The fascia of the tensor muscle is identified and incised. The muscle is swept digitally laterally and a retractor is placed over the superior aspect of the femoral neck. The hip capsule is then incised and retracted. Receives: Procedure: Direct Anterior Approach |
| Mini-Posterior Approach | Active comparator | The surgical approach involved a 7 to 9.5 cm incision along the posterior aspect of the femur starting at the tip of the greater trochanter and proceeding distally. The fascia of the gluteus maximus was split, and blunt dissection revealed the underlying abductor and external rotator musculature. The external rotators an the hip capsule were incised and preserved as one layer, with an attempt being made to preserve the insertion of the quadratus femoris on the femur. The hip was dislocated posteriorly and the femoral neck was cut in accordance with the preoperative plan. Receives: Procedure: Mini-Posterior Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity monitors will be worn
3 monitoring sensors will be worn by the subject.
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJan 2013
- Primary completion31 Dec 2017
- Study completion27 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Taunton, M.D., Mayo Clinic
- Investigators
- Michael Taunton, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613508
- Sponsor's protocol ID
- 12-001341
- Status last verified
- Dec 2018
- First submitted
- 5 Jun 2012
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Direct Anterior Approach and Mini-Posterior Approach Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01613508
- Acronym / sponsor ID
- 12-001341
- Conditions
- Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 7 Jun 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.
The primary aim of the study is to compare the results of an established, successful procedure, which is total hip arthroplasty through a mini-posterior approach to a less studied - increasingly popular procedure, which is total hip replacement through the direct anterior approach utilizing the orthopedic table.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Anterior Approach | Active comparator | Procedure: Direct Anterior ApproachAn oblique incision is made over the anterior margin of the tensor muscle. The fascia of the tensor muscle is identified and incised. The muscle is swept digitally laterally and a retractor is placed over the superior aspect of the femoral neck. The hip capsule is then incised and retracted. |
| Mini-Posterior Approach | Active comparator | Procedure: Mini-Posterior ApproachThe surgical approach involved a 7 to 9.5 cm incision along the posterior aspect of the femur starting at the tip of the greater trochanter and proceeding distally. The fascia of the gluteus maximus was split, and blunt dissection revealed the underlying abductor and external rotator musculature. The external rotators an the hip capsule were incised and preserved as one layer, with an attempt being made to preserve the insertion of the quadratus femoris on the femur. The hip was dislocated posteriorly and the femoral neck was cut in accordance with the preoperative plan. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female patients between 20 and 100 with unilateral osteoarthritis (DJD) who are surgical candidates for total hip arthroplasty
- Study participants must be able to give informed consent.
Key exclusion criteria (10 listed)
- Significant proximal femoral deformity (post SCFE, Perthes, DDH), acetabular dysplasia (ANY CROWE), inflammatory arthritis, septic arthritis, osteomyelitis, prior infection of hip joint, significant leg length discrepancy (> 4cm), osteoporosis, arthrodesis of the affected hip.
- The presence of infections, highly communicable diseases, e.g. AIDS, active tuberculosis, venereal disease, hepatitis.
- Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
- Presence of previous prosthetic hip replacement device (any type).
- Active Metastatic disease
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 |
|---|---|---|
| Direct Anterior Approach | Procedure or surgery | Direct Anterior Approach |
| Mini-Posterior Approach | Procedure or surgery | Mini-Posterior Approach |
Primary outcome
Activity monitors will be worn
Time frame: Baseline to 1 year
3 monitoring sensors will be worn by the subject.
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 5 Dec 2018.
Related trials for Total Hip Replacement
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
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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.
Michael Taunton, MD principal investigator
Mayo 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 Direct Anterior Approach and Mini-Posterior Approach in people with Total Hip Replacement, run by Mayo 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 2 inclusion and 10 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 5 Dec 2018. 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?
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?
Activity monitors will be worn (time frame: Baseline to 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 5 Dec 2018.