Osteoarthritis of the HipNCT01807104
Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
A study testing Anterior Approach / Posterior Approach and Anterior versus Posterior Approach for total hip replacement in people with Osteoarthritis of the Hip, run by Barrett, William, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to compare the short term effectiveness and return to function of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on the front part of the hip joint) versus Posterior Approach (incision over back part of the hip joint). Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Hip
- What is being tested?
- Anterior Approach / Posterior Approach and Anterior versus Posterior Approach for total hip replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to 20 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is able to or capable of providing consent to participate in the clinical investigation.
- Subject is between the ages of 20-75 years, inclusive.
- Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)
- Subject has sufficient bone stock for the hip replacement device.
- Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either surgical approach.
Who cannot join
- Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.
- Subject has had previous surgery on the affected hip.
- Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Valley Orthopedic Associates
Renton, Washington, 98055
About this study
Official title: Prospective Randomized Single Center Clinical Evaluation of THA Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
The purpose of this study is to compare the short term effectiveness and return to function of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on the front part of the hip joint) versus Posterior Approach (incision over back part of the hip joint).
Read the detailed description
The anterior approach may provide better early post-operative outcomes because there are fewer muscles at the front of the hip so the surgeon works between them rather than cutting through muscle fibers. However, the anterior approach is more difficult to access so usually requires a specialized table.
The posterior approach is easier to access, but the incision cuts through muscle fiber. This may lengthen recovery time. However, a specialized table, which can be quite expensive, is often not required.
- Conditions
- Osteoarthritis of the Hip
- Being tested
- Anterior Approach / Posterior Approach, Anterior versus Posterior Approach for total hip replacement
- Keywords
- Anterior Approach, Posterior Approach
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Approach / Posterior ApproachProcedure or surgery
compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach
Anterior versus Posterior Approach for total hip replacementProcedure or surgery
Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach
| Study group | Role | What they receive |
|---|---|---|
| Anterior Approach Total Hip | Active comparator | Total hip arthroplasty performed through an anterior surgical approach. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach Receives: Procedure: Anterior Approach / Posterior Approach |
| Posterior Approach Total Hip | Active comparator | The additional arm is the posterior approach total hip, which the Anterior Approach is being compared too. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach. Receives: Procedure: Anterior versus Posterior Approach for total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach
Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.
Measured: 5 years
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 startJan 2010
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the HipStudies 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barrett, William, M.D.
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, William Barrett, M.D., Barrett, William, M.D.
- Investigators
- William P Barrett, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807104
- Sponsor's protocol ID
- 20091819
- Status last verified
- Jul 2019
- First submitted
- 16 Jun 2011
- Last updated
- 29 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Single Center Clinical Evaluation of THA Surgical Techniques Comparing the Direct Anterior Approach to the Posterior Approach
- ClinicalTrials.gov ID
- NCT01807104
- Acronym / sponsor ID
- 20091819
- Conditions
- Osteoarthritis of the Hip
- Keywords
- Anterior Approach, Posterior Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Barrett, William, M.D.
- Collaborators
- Johnson & Johnson
- Study start
- Jan 2010 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Posted 29 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the short term effectiveness and return to function of subjects undergoing primary Total Hip Arthroplasty using an Anterior Approach (incision on the front part of the hip joint) versus Posterior Approach (incision over back part of the hip joint).
Detailed description
The anterior approach may provide better early post-operative outcomes because there are fewer muscles at the front of the hip so the surgeon works between them rather than cutting through muscle fibers. However, the anterior approach is more difficult to access so usually requires a specialized table.
The posterior approach is easier to access, but the incision cuts through muscle fiber. This may lengthen recovery time. However, a specialized table, which can be quite expensive, is often not required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Approach Total Hip | Active comparator | Procedure: Anterior Approach / Posterior ApproachTotal hip arthroplasty performed through an anterior surgical approach. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach |
| Posterior Approach Total Hip | Active comparator | Procedure: Anterior versus Posterior Approach for total hip replacementThe additional arm is the posterior approach total hip, which the Anterior Approach is being compared too. Compare results of total hip arthroplasty performed through either an Anterior or Posterior Surgical Approach. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is able to or capable of providing consent to participate in the clinical investigation.
- Subject is between the ages of 20-75 years, inclusive.
- Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD)
- Subject has sufficient bone stock for the hip replacement device.
- Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either surgical approach.
Key exclusion criteria (3 listed)
- Subject in the opinion of the Investigator has an existing condition that would compromise his /her participation and follow-up in this investigation.
- Subject has had previous surgery on the affected hip.
- Subject has significant osteoarthritis of the contra-lateral hip requiring a total hip arthroplasty within 12 months.
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 Approach / Posterior Approachcompare results of total hip arthroplasty performed through either an anterior or posterior surgical approach | Procedure or surgery | Anterior Approach Total Hip |
| Anterior versus Posterior Approach for total hip replacementCompare results of total hip arthroplasty performed through either an anterior or posterior surgical approach | Procedure or surgery | Posterior Approach Total Hip |
Primary outcome
Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach
Time frame: 5 years
Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Prospective, Randomized Study of Direct Anterior Approach vs Posterolateral Approach Total Hip Arthroplasty: A Concise 5-Year Follow-Up EvaluationLink provided by the sponsor.
Related trials for Osteoarthritis of the Hip
Active, not recruiting
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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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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.
William P Barrett, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Approach / Posterior Approach and Anterior versus Posterior Approach for total hip replacement in people with Osteoarthritis of the Hip, run by Barrett, William, M.D. 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 5 inclusion and 3 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 29 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach (time frame: 5 years). 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 29 Aug 2019.