Osteoarthritis, HipAAPNCT01353885
Outcomes Following Anterior Approach to Total Hip Arthroplasty
An observational study of Osteoarthritis, Hip, run by McMaster University at 1 site in Canada.
Trial summary
Osteoarthritis disables approximately 10% of people who are 60 years or older and compromises the quality of life of more than 20 million Americans every year. Osteoarthritis is caused by the breakdown of cartilage that lines the bones at your joints from daily wear and tear and results in pain and restricted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Oct 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men or women who are 18 years of age or older with a primary diagnosis of hip arthritis (radiographically and clinically). Patients must be undergoing an unilateral THA and have had no previous major hip surgery (hip arthroscopy is permitted) or hardware implanted in their hip.
Who may be able to join
- Men or women who are 18 years of age or older.
- Primary diagnosis of hip arthritis (radiographically and clinically).
- Patients undergoing an unilateral THA.
- Provision of informed consent by patient.
Who cannot join
- Patients being managed with alternative approaches (other than anterior, anterolateral or posterior THA) will be excluded.
- Patients undergoing a revision THA.
- Patients undergoing a bilateral THA.
- Patients with infection around the hip (soft tissue or bone).
- Patients who have had previous major hip surgery (hip arthroscopy is permitted) or hardware implanted in their hip.
- Patients who are currently enrolled in another surgical intervention trial.
- Patient has cognitive or language barriers that would limit completion of quality of life, pain, and function questionnaires in English.
- Anticipated problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes Following Anterior Approach to Total Hip Arthroplasty: A Multi-Centre Observational Cohort Study
Osteoarthritis disables approximately 10% of people who are 60 years or older and compromises the quality of life of more than 20 million Americans every year. Osteoarthritis is caused by the breakdown of cartilage that lines the bones at your joints from daily wear and tear and results in pain and restricted function. Total hip arthroplasty (THA) or total hip replacement, is currently one of the most successful and cost-effective treatments used to eliminate pain and restore function in those suffering from osteoarthritis. There are multiple ways to perform a THA. The main difference between each type is the point of incision in relation to a muscle on the outer surface of your hip bone: gluteus medius. The incision performed can be anterior (in front of the muscle), anterolateral (in front and to the side of the muscle), or posterior (from the back). Each of these approaches has its own advantages and disadvantages, but there is no evidence available that makes one better than the other. The purpose of this study is to determine which of the three approaches to THA is the most effective. The main outcome that will determine the most effective approach is the functional ability of the patients included in this study at 52 weeks. The investigators will also compare whether the patient's: length of hospital stay, use of assistive devices, need for revision surgery, ability to return to work, ability to relieve pain, complication rate, and quality of life. The investigators hypothesize that the anterior approach will be the most effective approach in reducing the rate of post-operative complications after THA.
- Conditions
- Osteoarthritis, Hip
- Keywords
- Primary Osteoarthritis, Hip, Total Hip Arthroplasty, Anterior Approach, Posterior Approach, Anterolateral Approach, Cohort Study, Outcomes, Complication Rate, Outcomes, Quality of Life
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Approach THA | 500 Patients will be included who have received a total hip arthroplasty using the Anterior Approach. The anterior approach to total hip arthroplasty refers to an internervous approach to the hip, where the incision is made from the middle of the iliac crest, then curved distally and laterally to the anterior superior iliac spine (Kelmanovich et al., 2003). To optimize feasibility and applicability of our results, we will not standardize the use of cemented components, the implant manufacturer, or the femoral head size. Surgeons will use the manufacturer specific guides for insertion of the total hip arthroplasty. | |
| Posterior Approach THA | 100 patients will be enrolled who have received a total hip arthroplasty using the posterior approach. The posterior approach is performed by making a curved incision posteriorly on the greater trochanter (Jolles \& Bogoch, 2004). The fascia lata is then incised and the fibers of the gluteus maximus split using dissection (Jolles \& Bogoch, 2004). To ensure the feasibility and applicability of our findings, we will not standardize the use of cemented components, the implant manufacturer, or the femoral head size used in the posterior approach. | |
| Anterolateral Approach THA | 100 patients will be enrolled who have had a total hip arthroplasty using the anterolateral approach. An anterolateral approach to THA utilizes an intermuscular approach by incising the patient posteriorly and distally to the anterior superior iliac spine, extending distally to the greater trochanter along the shaft of the femur (Kelmanovich et al., 2003). To optimize the feasibility and applicability of our results, the implant manufacturer, femoral head size or the use of cemented components will not be standardized in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Functional Ability
Measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaire.
Measured: 52 Weeks
Secondary outcomes (9)
Technical Parameters
Length of Incision (cm), Blood Loss (mL), Fluoroscopy Time (s), Operative Time (Min)
Measured: 1 day - measured during and post-operatively
Length of Hospital Stay
Duration of time patient is in hospital post-operatively.
Measured: 4 weeks
Use of Assistive Device
Presence of an assistive device(s) provided to patients at discharge and the length of time it takes the patient to discard the assistive device(s).
Measured: 52 weeks
Revision Surgery
Occurrence and type of revision surgery required (if any)
Measured: 52 weeks
Ability to participate in sports activities
Subjectively reported.
Measured: 52 weeks
Return to Work
Measured by the Work Limitations Questionnaire (WLQ)- short form format
Measured: 52 Weeks
Complication Rate
We will define complications in patients as a constellation of clinical symptoms and laboratory examinations. These will include (but are not limited to) both intraoperative and postoperative complications; More specifically, musculoskeletal, cardiovascular, psychological, neurological, genitourinary, and wound-related complications.
Measured: 52 Weeks
Pain
Measured by the EuroQol-5d (EQ-5D) and Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaires.
Measured: 52 Weeks
Quality of Life
Measured by the EuroQol-5d (EQ-5D) and Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaires.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Mohit Bhandari, MD, PhD, FRCSC, Principal investigator, McMaster UniversityJoel Matta, MD, Principal investigator, St. Joseph's Health Centre Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353885
- Sponsor's protocol ID
- Depuy-05072
- Acronym
- AAP
- Status last verified
- Aug 2014
- First submitted
- 11 May 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jolles BM, Bogoch ER. Surgical approach for total hip arthroplasty: direct lateral or posterior? J Rheumatol. 2004 Sep;31(9):1790-6.
PubMed 15338502Kelmanovich D, Parks ML, Sinha R, Macaulay W. Surgical approaches to total hip arthroplasty. J South Orthop Assoc. 2003 Summer;12(2):90-4.
PubMed 12882247
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Following Anterior Approach to Total Hip Arthroplasty: A Multi-Centre Observational Cohort Study
- ClinicalTrials.gov ID
- NCT01353885
- Acronym / sponsor ID
- AAP / Depuy-05072
- Conditions
- Osteoarthritis, Hip
- Keywords
- Primary Osteoarthritis, Hip, Total Hip Arthroplasty, Anterior Approach, Posterior Approach, Anterolateral Approach, Cohort Study, Outcomes, Complication Rate, Outcomes, Quality of Life
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 May 2011 (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.
Osteoarthritis disables approximately 10% of people who are 60 years or older and compromises the quality of life of more than 20 million Americans every year. Osteoarthritis is caused by the breakdown of cartilage that lines the bones at your joints from daily wear and tear and results in pain and restricted function. Total hip arthroplasty (THA) or total hip replacement, is currently one of the most successful and cost-effective treatments used to eliminate pain and restore function in those suffering from osteoarthritis. There are multiple ways to perform a THA. The main difference between each type is the point of incision in relation to a muscle on the outer surface of your hip bone: gluteus medius. The incision performed can be anterior (in front of the muscle), anterolateral (in front and to the side of the muscle), or posterior (from the back). Each of these approaches has its own advantages and disadvantages, but there is no evidence available that makes one better than the other. The purpose of this study is to determine which of the three approaches to THA is the most effective. The main outcome that will determine the most effective approach is the functional ability of the patients included in this study at 52 weeks. The investigators will also compare whether the patient's: length of hospital stay, use of assistive devices, need for revision surgery, ability to return to work, ability to relieve pain, complication rate, and quality of life. The investigators hypothesize that the anterior approach will be the most effective approach in reducing the rate of post-operative complications after THA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior Approach THA | – | –500 Patients will be included who have received a total hip arthroplasty using the Anterior Approach. The anterior approach to total hip arthroplasty refers to an internervous approach to the hip, where the incision is made from the middle of the iliac crest, then curved distally and laterally to the anterior superior iliac spine (Kelmanovich et al., 2003). To optimize feasibility and applicability of our results, we will not standardize the use of cemented components, the implant manufacturer, or the femoral head size. Surgeons will use the manufacturer specific guides for insertion of the total hip arthroplasty. |
| Posterior Approach THA | – | –100 patients will be enrolled who have received a total hip arthroplasty using the posterior approach. The posterior approach is performed by making a curved incision posteriorly on the greater trochanter (Jolles \& Bogoch, 2004). The fascia lata is then incised and the fibers of the gluteus maximus split using dissection (Jolles \& Bogoch, 2004). To ensure the feasibility and applicability of our findings, we will not standardize the use of cemented components, the implant manufacturer, or the femoral head size used in the posterior approach. |
| Anterolateral Approach THA | – | –100 patients will be enrolled who have had a total hip arthroplasty using the anterolateral approach. An anterolateral approach to THA utilizes an intermuscular approach by incising the patient posteriorly and distally to the anterior superior iliac spine, extending distally to the greater trochanter along the shaft of the femur (Kelmanovich et al., 2003). To optimize the feasibility and applicability of our results, the implant manufacturer, femoral head size or the use of cemented components will not be standardized in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men or women who are 18 years of age or older with a primary diagnosis of hip arthritis (radiographically and clinically). Patients must be undergoing an unilateral THA and have had no previous major hip surgery (hip arthroscopy is permitted) or hardware implanted in their hip.
Key inclusion criteria (4 listed)
- Men or women who are 18 years of age or older.
- Primary diagnosis of hip arthritis (radiographically and clinically).
- Patients undergoing an unilateral THA.
- Provision of informed consent by patient.
Key exclusion criteria (8 listed)
- Patients being managed with alternative approaches (other than anterior, anterolateral or posterior THA) will be excluded.
- Patients undergoing a revision THA.
- Patients undergoing a bilateral THA.
- Patients with infection around the hip (soft tissue or bone).
- Patients who have had previous major hip surgery (hip arthroscopy is permitted) or hardware implanted in their hip.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Functional Ability
Time frame: 52 Weeks
Measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaire.
9 secondary outcomes
Technical Parameters
Time frame: 1 day - measured during and post-operatively
Length of Hospital Stay
Time frame: 4 weeks
Use of Assistive Device
Time frame: 52 weeks
Revision Surgery
Time frame: 52 weeks
Ability to participate in sports activities
Time frame: 52 weeks
Return to Work
Time frame: 52 Weeks
Complication Rate
Time frame: 52 Weeks
Pain
Time frame: 52 Weeks
Quality of Life
Time frame: 52 Weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Background: PubMed 15338502Jolles BM, Bogoch ER. Surgical approach for total hip arthroplasty: direct lateral or posterior? J Rheumatol. 2004 Sep;31(9):1790-6.
- Background: PubMed 12882247Kelmanovich D, Parks ML, Sinha R, Macaulay W. Surgical approaches to total hip arthroplasty. J South Orthop Assoc. 2003 Summer;12(2):90-4.
Related trials for Osteoarthritis, Hip
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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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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.
Mohit Bhandari, MD, PhD, FRCSC principal investigator
McMaster University
Joel Matta, MD principal investigator
St. Joseph's Health Centre Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip, run by McMaster University at 1 site in Canada.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 Aug 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 Canada. 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 was stopped early. 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?
Patient Functional Ability (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01353885, which also lists 2 linked publications.
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 13 Aug 2014.