OsteoarthritisNCT01024309
A Trial Comparing Mini-posterior Approach and Direct Anterior Approach
A study testing Mini-Posterior surgical approach for total hip arthroplasty and Direct Anterior surgical approach for total hip arthroplasty in people with Osteoarthritis, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose is to determine if differences exist in the attainment of functional milestones that reflect activities of daily living between mini-posterior and direct anterior approach total hip arthroplasty (THA). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Mini-Posterior surgical approach for total hip arthroplasty and Direct Anterior surgical approach for total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2013
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is willing and able to understand, sign and date the study specific Patient Informed Consent and Health Insurance Portability and Accountability Act (HIPPA) authorization to volunteer participation in the study.
- The subject is between 25 and 80 years of age at the time of surgery.
- The subject has elected to undergo primary total hip arthroplasty for osteoarthritis.
- The subject is psychosocially, mentally and physically able to comply with the requirements of the study including post-operative clinical, radiographic evaluations and completion of patient questionnaires.
- The subject is skeletally mature.
Who cannot join
- The subject has a BMI greater than 35.
- The subject has had a previous total hip arthroplasty.
- The subject has inflammatory arthritis.
- The subject has any type of infection.
- The subject has developmental dysplasia of the hip.
- The subject has a known metal allergy.
Show all 11Show fewer
- The subject has an extreme offset of greater than 50 mm.
- The subject has an acetabular deformity requiring advanced reconstructive techniques.
- The subject has Charcot's disease.
- The subject has Paget's disease
- Dependence on narcotics for 6 months (or longer)
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoCarolina, P.A.
Charlotte, North Carolina, 28207
About this study
Official title: A Prospective, Randomized, Clinical Trial Comparing the Clinical Outcomes Following Total Hip Arthroplasty by a Single Surgeon Using Either a Mini-posterior Approach or a Direct Anterior Approach
The purpose is to determine if differences exist in the attainment of functional milestones that reflect activities of daily living between mini-posterior and direct anterior approach total hip arthroplasty (THA). The investigators also hope to determine if the general health outcome after direct anterior total hip arthroplasty was better than that after mini-posterior-incision total hip arthroplasty as measured with Short Form-12 (SF-12) scores, and to evaluate variation of surgical factors of the two procedures on the basis of the operative time, component positioning, and occurrence of early complications.
Read the detailed description
A number of studies have compared surgical approach for total hip arthroplasty. The influence of surgical outcome as a function of approach comparing mini-posterior to direct anterior has not been reported in a randomized, prospective manner.
Standard primary total hip arthroplasty (THA) can reliably alleviate pain, improve function, and improve the quality of life in a broad section of patients with end stage arthrosis of the hip. However, minimally invasive approaches, such as the direct anterior and mini-posterior approaches, have been devised with the goal of decreasing peri-operative pain, speed early postoperative function, and improve patient satisfaction with the procedure, compared with standard THA. These patient centered goals are combined with the surgeon's desire of a safe, reproducible minimally invasive procedure that has durable, properly positioned components.
There are currently no prospective, randomized studies comparing the direct anterior approach to total hip arthroplasty with other minimally invasive approaches. The mini-posterior approach has been studied extensively, with promising results. Others have compared the mini-posterior approach with other minimally invasive procedures, and at the current time, has the most prospective data demonstrating its superiority as a minimally invasive approach. Pagnano performed a prospective, randomized trial comparing the early clinical results of mini -posterior THA with Two-incision THA. The results found that the early attainment of functional milestones was shorter in the mini-posterior group.
The purpose is to determine if differences exist in the attainment of functional milestones that reflect activities of daily living between mini-posterior and direct anterior approach total hip arthroplasty (THA). The investigators also hope to determine if the general health outcome after direct anterior total hip arthroplasty was better than that after mini-posterior-incision total hip arthroplasty as measured with Short Form-12 (SF-12) scores, and to evaluate variation of surgical factors of the two procedures on the basis of the operative time, component positioning, and occurrence of early complications.
- Conditions
- Osteoarthritis
- Being tested
- Mini-Posterior surgical approach for total hip arthroplasty, Direct Anterior surgical approach for total hip arthroplasty
- Keywords
- total hip arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-Posterior surgical approach for total hip arthroplastyProcedure or surgery
Mini-Posterior surgical approach for total hip arthroplasty
Direct Anterior surgical approach for total hip arthroplastyProcedure or surgery
Direct Anterior surgical approach for total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Mini-Posterior Approach | Active comparator | Mini-Posterior surgical approach for total hip arthroplasty Receives: Procedure: Mini-Posterior surgical approach for total hip arthroplasty |
| Direct Anterior Approach | Experimental | Direct Anterior surgical approach for total hip arthroplasty Receives: Procedure: Direct Anterior surgical approach for total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days for Discontinue Assistive Devices
The primary early functional endpoint is the difference between groups in the postoperative days that patients require any assistive devices for ambulation. Lower number of days indicate better outcomes.
Measured: 6 week
Secondary outcomes (8)
Harris Hip Score
The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points).
Measured: 3 week
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.
Measured: 3 week
Abduction Angle
Abduction angle is a radiographic measure of implant position. 40 degrees of abduction is optimal. 30-50 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 40 degrees indicate better placement.
Measured: 6 wk
Anteversion Angle
Anteversion angle is a radiographic measure of implant position. 35 degrees of anteversion is optimal. 25-45 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 35 degrees indicate better placement.
Measured: 6 week
Harris Hip Score
The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points).
Measured: 6 week
WOMAC
Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.
Measured: 6 week
Harris Hip Score
The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points).
Measured: 12 month
WOMAC
Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2013
- Study completionSep 2013
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 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Bohannon Mason, MD, Principal investigator, OrthoCarolina, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024309
- Sponsor's protocol ID
- 09072
- Status last verified
- Oct 2014
- First submitted
- 30 Nov 2009
- Last updated
- 30 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Clinical Trial Comparing the Clinical Outcomes Following Total Hip Arthroplasty by a Single Surgeon Using Either a Mini-posterior Approach or a Direct Anterior Approach
- ClinicalTrials.gov ID
- NCT01024309
- Acronym / sponsor ID
- 09072
- Conditions
- Osteoarthritis
- Keywords
- total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 30 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to determine if differences exist in the attainment of functional milestones that reflect activities of daily living between mini-posterior and direct anterior approach total hip arthroplasty (THA). The investigators also hope to determine if the general health outcome after direct anterior total hip arthroplasty was better than that after mini-posterior-incision total hip arthroplasty as measured with Short Form-12 (SF-12) scores, and to evaluate variation of surgical factors of the two procedures on the basis of the operative time, component positioning, and occurrence of early complications.
Detailed description
A number of studies have compared surgical approach for total hip arthroplasty. The influence of surgical outcome as a function of approach comparing mini-posterior to direct anterior has not been reported in a randomized, prospective manner.
Standard primary total hip arthroplasty (THA) can reliably alleviate pain, improve function, and improve the quality of life in a broad section of patients with end stage arthrosis of the hip. However, minimally invasive approaches, such as the direct anterior and mini-posterior approaches, have been devised with the goal of decreasing peri-operative pain, speed early postoperative function, and improve patient satisfaction with the procedure, compared with standard THA. These patient centered goals are combined with the surgeon's desire of a safe, reproducible minimally invasive procedure that has durable, properly positioned components.
There are currently no prospective, randomized studies comparing the direct anterior approach to total hip arthroplasty with other minimally invasive approaches. The mini-posterior approach has been studied extensively, with promising results. Others have compared the mini-posterior approach with other minimally invasive procedures, and at the current time, has the most prospective data demonstrating its superiority as a minimally invasive approach. Pagnano performed a prospective, randomized trial comparing the early clinical results of mini -posterior THA with Two-incision THA. The results found that the early attainment of functional milestones was shorter in the mini-posterior group.
The purpose is to determine if differences exist in the attainment of functional milestones that reflect activities of daily living between mini-posterior and direct anterior approach total hip arthroplasty (THA). The investigators also hope to determine if the general health outcome after direct anterior total hip arthroplasty was better than that after mini-posterior-incision total hip arthroplasty as measured with Short Form-12 (SF-12) scores, and to evaluate variation of surgical factors of the two procedures on the basis of the operative time, component positioning, and occurrence of early complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-Posterior Approach | Active comparator | Procedure: Mini-Posterior surgical approach for total hip arthroplastyMini-Posterior surgical approach for total hip arthroplasty |
| Direct Anterior Approach | Experimental | Procedure: Direct Anterior surgical approach for total hip arthroplastyDirect Anterior surgical approach for total hip arthroplasty |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is willing and able to understand, sign and date the study specific Patient Informed Consent and Health Insurance Portability and Accountability Act (HIPPA) authorization to volunteer participation in the study.
- The subject is between 25 and 80 years of age at the time of surgery.
- The subject has elected to undergo primary total hip arthroplasty for osteoarthritis.
- The subject is psychosocially, mentally and physically able to comply with the requirements of the study including post-operative clinical, radiographic evaluations and completion of patient questionnaires.
- The subject is skeletally mature.
Key exclusion criteria (11 listed)
- The subject has a BMI greater than 35.
- The subject has had a previous total hip arthroplasty.
- The subject has inflammatory arthritis.
- The subject has any type of infection.
- The subject has developmental dysplasia of the hip.
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 |
|---|---|---|
| Mini-Posterior surgical approach for total hip arthroplastyMini-Posterior surgical approach for total hip arthroplasty | Procedure or surgery | Mini-Posterior Approach |
| Direct Anterior surgical approach for total hip arthroplastyDirect Anterior surgical approach for total hip arthroplasty | Procedure or surgery | Direct Anterior Approach |
Primary outcome
Number of Days for Discontinue Assistive Devices
Time frame: 6 week
The primary early functional endpoint is the difference between groups in the postoperative days that patients require any assistive devices for ambulation. Lower number of days indicate better outcomes.
8 secondary outcomes
Harris Hip Score
Time frame: 3 week
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 3 week
Abduction Angle
Time frame: 6 wk
Anteversion Angle
Time frame: 6 week
Harris Hip Score
Time frame: 6 week
WOMAC
Time frame: 6 week
Harris Hip Score
Time frame: 12 month
WOMAC
Time frame: 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John Bohannon Mason, MD principal investigator
OrthoCarolina, P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-Posterior surgical approach for total hip arthroplasty and Direct Anterior surgical approach for total hip arthroplasty in people with Osteoarthritis, run by OrthoCarolina Research Institute, Inc. 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 11 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 30 Oct 2014. 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 30 Oct 2014). 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?
Number of Days for Discontinue Assistive Devices (time frame: 6 week). 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 30 Oct 2014.