OsteoarthritisNCT00594893
Study Comparing Mini-Incision Versus 2-Incision Approach for Total Hip Replacement
A study testing Mini Incision Approach and 2 Incision Approach in people with Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of the research is to determine if there is a difference between two of the commonly used less invasive techniques (surgical methods that use a smaller incision or cut in the skin) used to perform total hip arthroplasty (replacement of your painful hip with a new ball and socket). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Mini Incision Approach and 2 Incision Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of hip osteoarthritis
- age greater than 18 years
- willingness to undergo a neuraxial anesthetic for the procedure
- female patient greater than one year postmenopausal, surgically sterile or using an accepted form of contraception
Who cannot join
- use of any medication that may impact platelet aggregation within 10 days of surgery
- chronic use of coumadin for anticoagulation
- the use of low molecular weight heparin postoperatively
- clinically significant systemic disease or laboratory abnormalities
- a primary hematologic disorder
- recent gastrointestinal or intracranial bleeding
Show all 11Show fewer
- any contraindication to anticoagulant use
- history of previous ipsilateral hip surgery
- a body mass index of greater than 30
- significant hip deformity that precludes the use of standard implants
- use of ONLY general anesthetic during surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Prospective Randomized Trial of Mini Incision and 2-Incision Total Hip Arthroplasty
The purpose of the research is to determine if there is a difference between two of the commonly used less invasive techniques (surgical methods that use a smaller incision or cut in the skin) used to perform total hip arthroplasty (replacement of your painful hip with a new ball and socket). It is unclear which of these techniques is associated with a faster recovery and lower risk of complications.
Read the detailed description
Recently, surgical techniques and surgical instruments have been developed to limit the dissection required to perform a total hip arthroplasty. Proponents of these procedures feel that it is associated with less perioperative blood loss, less pain and an accelerated recovery while critics have raised concerns that the more limited exposure may negatively impact component position and increase the risk of perioperative complications. Among less invasive surgical techniques, two of the different approaches utilized include a "mini-incision" posterior approach which aims to limit the amount of dissection associated with a standard posterior approach to the hip and a 2-incision technique which seeks to further limit soft tissue disruption by taking advantage of intermuscular planes and the use of fluoroscopic guidance.
While the mini-posterior approach utilizes an abbreviated exposure which is familiar to most surgeons, the 2-incision approach is a more novel approach and critics of this approach feel that its technically demanding nature may be associated with a higher risk of complications and component malposition. Proponents of the 2-incision approach feel that this approach is less invasive, more muscle sparing and leads to substantial improvements in patient rehabilitation and recovery with potential longer-term benefits in terms of improved function. The goal of this project is to compare the use of a mini-incision posterior approach and the 2-incision approach in primary total hip arthroplasty via a prospective randomized trial.
- Conditions
- Osteoarthritis
- Being tested
- Mini Incision Approach, 2 Incision Approach
- Keywords
- Hip, Arthroplasty, Minimally Invasive
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Incision ApproachProcedure or surgery
Mini Incision Approach
2 Incision ApproachProcedure or surgery
2 Incision Approach
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Mini Incision Approach Receives: Procedure: Mini Incision Approach |
| 2 | Active comparator | 2 Incision Approach Receives: Procedure: 2 Incision Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Measured: Daily for 6 weeks postoperatively
Secondary outcomes (1)
Functional milestones
Measured: daily for 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJun 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Craig J Delle Valle, Rush University Medical Center
- Investigators
- Craig J DellaValle, MD, Principal investigator, Rush University Medical Center, Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594893
- Sponsor's protocol ID
- CDV-05061503
- Status last verified
- Aug 2012
- First submitted
- 7 Jan 2008
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Della Valle CJ, Dittle E, Moric M, Sporer SM, Buvanendran A. A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty. Clin Orthop Relat Res. 2010 Dec;468(12):3348-54. doi: 10.1007/s11999-010-1491-5. Epub 2010 Jul 29.
PubMed 20668969
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Mini Incision and 2-Incision Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00594893
- Acronym / sponsor ID
- CDV-05061503
- Conditions
- Osteoarthritis
- Keywords
- Hip, Arthroplasty, Minimally Invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Jun 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Jan 2008 (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 purpose of the research is to determine if there is a difference between two of the commonly used less invasive techniques (surgical methods that use a smaller incision or cut in the skin) used to perform total hip arthroplasty (replacement of your painful hip with a new ball and socket). It is unclear which of these techniques is associated with a faster recovery and lower risk of complications.
Detailed description
Recently, surgical techniques and surgical instruments have been developed to limit the dissection required to perform a total hip arthroplasty. Proponents of these procedures feel that it is associated with less perioperative blood loss, less pain and an accelerated recovery while critics have raised concerns that the more limited exposure may negatively impact component position and increase the risk of perioperative complications. Among less invasive surgical techniques, two of the different approaches utilized include a "mini-incision" posterior approach which aims to limit the amount of dissection associated with a standard posterior approach to the hip and a 2-incision technique which seeks to further limit soft tissue disruption by taking advantage of intermuscular planes and the use of fluoroscopic guidance.
While the mini-posterior approach utilizes an abbreviated exposure which is familiar to most surgeons, the 2-incision approach is a more novel approach and critics of this approach feel that its technically demanding nature may be associated with a higher risk of complications and component malposition. Proponents of the 2-incision approach feel that this approach is less invasive, more muscle sparing and leads to substantial improvements in patient rehabilitation and recovery with potential longer-term benefits in terms of improved function. The goal of this project is to compare the use of a mini-incision posterior approach and the 2-incision approach in primary total hip arthroplasty via a prospective randomized trial.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Mini Incision ApproachMini Incision Approach |
| 2 | Active comparator | Procedure: 2 Incision Approach2 Incision Approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of hip osteoarthritis
- age greater than 18 years
- willingness to undergo a neuraxial anesthetic for the procedure
- female patient greater than one year postmenopausal, surgically sterile or using an accepted form of contraception
Key exclusion criteria (11 listed)
- use of any medication that may impact platelet aggregation within 10 days of surgery
- chronic use of coumadin for anticoagulation
- the use of low molecular weight heparin postoperatively
- clinically significant systemic disease or laboratory abnormalities
- a primary hematologic disorder
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 Incision ApproachMini Incision Approach | Procedure or surgery | 1 |
| 2 Incision Approach2 Incision Approach | Procedure or surgery | 2 |
Primary outcome
Pain scores
Time frame: Daily for 6 weeks postoperatively
1 secondary outcome
Functional milestones
Time frame: daily for 6 weeks postoperatively
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 31 Aug 2012.
- Results publication: PubMed 20668969Della Valle CJ, Dittle E, Moric M, Sporer SM, Buvanendran A. A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty. Clin Orthop Relat Res. 2010 Dec;468(12):3348-54. doi: 10.1007/s11999-010-1491-5. Epub 2010 Jul 29.
Related trials for Osteoarthritis
Not yet recruitingPhase 2
PPV-06 Vaccine in Inflammatory Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Boosting Exercise Adherence in Knee Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 4
Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Osteoarthritis Thumb
Not yet recruiting
Tempo-controlled Low-load Resistance Training in Patients With Knee Osteoarthritis.
Knee Osteoarthritis
Recruiting
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Thumb Osteoarthritis
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.
Craig J DellaValle, MD principal investigator
Rush University Medical Center, Department of Orthopaedics
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 Incision Approach and 2 Incision Approach in people with Osteoarthritis, run by Rush University Medical Center 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 4 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 31 Aug 2012. 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?
Pain scores (time frame: Daily for 6 weeks postoperatively). 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 NCT00594893, which also lists 1 linked publication.
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 31 Aug 2012.