Osteoarthritis, HipNCT01636375
Comparison of Muscle Atrophy After Direct Anterior & Posterior Total Hip Arthroplasty
An observational study of Osteoarthritis, Hip, run by Northwell Health at 1 site in United States.
Trial summary
This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the specific aims of this project are three-fold. First, the investigators intend to compare the amount of muscle atrophy and tendon damage that occurs around the hip between two commonly-used operative approaches: the direct-anterior… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing Total Hip arthroplasty by one of the two fellowship trained arthroplasty surgeons.
Who may be able to join
- Patients undergoing elective, primary total hip arthroplasty
- Use of Cementless Total Hip components
- Preoperative diagnosis of degenerative joint disease secondary to osteoarthritis
Who cannot join
- Prior surgery on the affected hip
- No implanted medical devices or metallic debris in the patient which will preclude use of MRI
- patients must be able to participate in standard post-arthroplasty rehabilitation protocols.
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShoreLIJ/LenoxHill Hospital
New York, New York, 10075
About this study
Official title: The Influence of Operative Approach on Muscle Atrophy After Total Hip Arthroplasty: A Comparison of Anterior and Posterior Approaches
This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the specific aims of this project are three-fold. First, the investigators intend to compare the amount of muscle atrophy and tendon damage that occurs around the hip between two commonly-used operative approaches: the direct-anterior approach and the posterior approach. Second, the investigators aim to provide baseline data on the amount of muscle atrophy and tendon damage that should reasonably be expected to occur with both of these approaches. Third, the investigators will document the degree of recovery of the periprosthetic soft tissues post-surgery in both patient groups.
The investigators first hypothesis is that the posterior approach will demonstrate significantly more damage to the abductors, piriformis, and short external rotators than the direct anterior approach, which will demonstrate minimal soft tissue damage. The investigators second hypothesis is that both surgical approaches will cause some degree of baseline muscle damage and atrophy, in a predictable pattern. The investigators third hypothesis is that each of the surgical approaches inherently cause some degree of soft tissue damage, and that the periprosthetic soft tissues that are incised during the surgical exposure will recover in a predictable pattern which is consistent but unique within each group
- Conditions
- Osteoarthritis, Hip
- 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 |
|---|---|---|
| Direct Anterior Approach | Not described | |
| Posterior Approach | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in muscle volume at 6 weeks
Muscle volume will be recorded in MRI images with specialized software (external rotators,tensor fascia lata, rectus femoris,gluteus medius and minimus)
Measured: 6 weeks after surgery
Change from baseline in muscle volume at 6 months
Measured: 6 months after surgery
Secondary outcomes (4)
Change in Fatty atrophy of muscles from baseline at 6weeks
Qualitative assessment of fatty atrophy
Measured: 6 weeks after surgery
tendon damage
Qualitative assessment of tendon damage on MRI
Measured: 6 weeks after surgery
Change in fatty atrophy of muscles from baseline at 6 months
Measured: 6 months after surgery
Tendon damage
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Rodriguez, MD, Northwell Health
- Investigators
- Jose A Rodriguez, MD, Principal investigator, NorthShoreLIJ/LenoxHill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636375
- Sponsor's protocol ID
- MRI DAA/PA
- Status last verified
- Nov 2021
- First submitted
- 29 Jun 2012
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Operative Approach on Muscle Atrophy After Total Hip Arthroplasty: A Comparison of Anterior and Posterior Approaches
- ClinicalTrials.gov ID
- NCT01636375
- Acronym / sponsor ID
- MRI DAA/PA
- Conditions
- Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 10 Jul 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.
This project is designed to use MRI to evaluate pre- and post-arthroplasty hips; the specific aims of this project are three-fold. First, the investigators intend to compare the amount of muscle atrophy and tendon damage that occurs around the hip between two commonly-used operative approaches: the direct-anterior approach and the posterior approach. Second, the investigators aim to provide baseline data on the amount of muscle atrophy and tendon damage that should reasonably be expected to occur with both of these approaches. Third, the investigators will document the degree of recovery of the periprosthetic soft tissues post-surgery in both patient groups.
The investigators first hypothesis is that the posterior approach will demonstrate significantly more damage to the abductors, piriformis, and short external rotators than the direct anterior approach, which will demonstrate minimal soft tissue damage. The investigators second hypothesis is that both surgical approaches will cause some degree of baseline muscle damage and atrophy, in a predictable pattern. The investigators third hypothesis is that each of the surgical approaches inherently cause some degree of soft tissue damage, and that the periprosthetic soft tissues that are incised during the surgical exposure will recover in a predictable pattern which is consistent but unique within each group
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Anterior Approach | – | – |
| Posterior Approach | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Total Hip arthroplasty by one of the two fellowship trained arthroplasty surgeons.
Key inclusion criteria (3 listed)
- Patients undergoing elective, primary total hip arthroplasty
- Use of Cementless Total Hip components
- Preoperative diagnosis of degenerative joint disease secondary to osteoarthritis
Key exclusion criteria (3 listed)
- Prior surgery on the affected hip
- No implanted medical devices or metallic debris in the patient which will preclude use of MRI
- patients must be able to participate in standard post-arthroplasty rehabilitation protocols.
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
Change from baseline in muscle volume at 6 weeks
Time frame: 6 weeks after surgery
Muscle volume will be recorded in MRI images with specialized software (external rotators,tensor fascia lata, rectus femoris,gluteus medius and minimus)
Change from baseline in muscle volume at 6 months
Time frame: 6 months after surgery
4 secondary outcomes
Change in Fatty atrophy of muscles from baseline at 6weeks
Time frame: 6 weeks after surgery
tendon damage
Time frame: 6 weeks after surgery
Change in fatty atrophy of muscles from baseline at 6 months
Time frame: 6 months after surgery
Tendon damage
Time frame: 6 months after surgery
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 19 Nov 2021.
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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.
Jose A Rodriguez, MD principal investigator
NorthShoreLIJ/LenoxHill Hospital
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 Northwell Health 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 3 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 19 Nov 2021. 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?
Change from baseline in muscle volume at 6 weeks (time frame: 6 weeks after surgery). The study lists 2 primary outcomes in all. 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 19 Nov 2021.