Hip InjuriesTHANCT01833481
THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches
An observational study of Hip Injuries, run by The University of Tennessee, Knoxville at 3 sites in 2 countries.
Trial summary
In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total Hip Arthroplasties (THA), it was determined that the investigators could simultaneously capture in vivo sound and motion of the femoral head within the acetabular cup during weight-bearing activities for subjects implanted with… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Hip Injuries
- What is being tested?
- Fluoroscopy surveillance of patients while walking
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2013to Sep 2014
- Phase
- Observational
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients implanted with a direct-anterior surgical approach will be provided by Dr. William Barrett of Valley Orthopedic Associates in Renton, WA. Patients implanted with an anterior-lateral surgical approach will be provided by Dr. of Steven J. MacDonald of the London Health Sciences Center, London, Ontario. Patients implanted with a posterior-lateral approach will be provided by Dr. David F. Dalury of Towson Orthopaedic Associates, Inc. in Towson, MD.
Who may be able to join
- Post-operative clinical evaluation judged successful using Harris Hip Scoring (HHS) system (HHS>90)
- Body weight less than 270 lbs
- No evidence of post-operative hip subluxation or dislocation
- Do not walk with detectable limp
- Be able to actively abduct their operated hip against gravity without difficulty
- Must be willing to sign Informed Consent and Health Insurance Portability and Accountability (HIPAA) forms
Who cannot join
- Pregnant, lactating or females not using reliable form of birth control
- Patients that do not meet study requirements
- Patients unwilling to sign Informed Consent or HIPAA forms
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Valley Orthopedic Associates ASC
Renton, Washington, 90855
University of Maryland St. Joseph Medical Center
Towson, Maryland, 21201
About this study
Official title: In Vivo Determination of THA Kinematics and Sound for Subject Implanted Using Various Surgical Approaches
In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total Hip Arthroplasties (THA), it was determined that the investigators could simultaneously capture in vivo sound and motion of the femoral head within the acetabular cup during weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP), metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA. This was the first study to apply sound analysis as an impulse excitation technique for testing hip conditions and for measuring femoral head sliding in the acetabular component of human hip joints by acoustic means. Unfortunately, no studies have been conducted to compare the in vivo kinematics and sound for subjects implanted using various surgical approaches. It could be hypothesized that subjects having various surgical approaches could lead to an increase or reduction of in vivo hip separation. Therefore, the objective of this study is to analyze a total of 30 subjects implanted with either an anterior (10 patients), anterior-lateral (10 patients), or posterior-lateral (10 patients) surgical approach to determine if any of these surgical approaches leads to less or more in vivo hip separation. All subjects will be analyzed under in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.
- Conditions
- Hip Injuries
- Being tested
- Fluoroscopy surveillance of patients while walking
- Keywords
- Surgical approach, Direct-anterior, Anterior-lateral, Posterior-lateral, Hip implant, Total Hip Arthroplasty, Total Hip replacement, Hip replacement, Hip prosthesis
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroscopy surveillance of patients while walkingRadiation
Also called DePuy Orthopaedics hip implant
While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
| Study group | Role | What they receive |
|---|---|---|
| THA using direct-anterior surgical approach | Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking. Receives: Radiation: Fluoroscopy surveillance of patients while walking | |
| THA using anterior-lateral approach | Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking. Receives: Radiation: Fluoroscopy surveillance of patients while walking | |
| THA using posterior-lateral approach | Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking. Receives: Radiation: Fluoroscopy surveillance of patients while walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics - Swing Phase Separation
Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.
Measured: 6 months post-operatively
Kinematics - Stance Phase Separation
Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.
Measured: 6 months post-operative
Kinematics - Overall Separation
Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance
Measured: 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
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 Hip InjuriesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Principal investigator, Richard Komistek, The University of Tennessee, Knoxville
- Investigators
- Richard D Komistek, Ph D, Principal investigator, The University of TennesseeAdrija Sharma, Ph D, Principal investigator, The University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833481
- Sponsor's protocol ID
- 12009
- Other IDs
- R01 1373 452, 13-0372
- Acronym
- THA
- Status last verified
- Oct 2019
- First submitted
- 11 Apr 2013
- Last updated
- 10 Oct 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 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Determination of THA Kinematics and Sound for Subject Implanted Using Various Surgical Approaches
- ClinicalTrials.gov ID
- NCT01833481
- Acronym / sponsor ID
- THA / 12009
- Conditions
- Hip Injuries
- Keywords
- Surgical approach, Direct-anterior, Anterior-lateral, Posterior-lateral, Hip implant, Total Hip Arthroplasty, Total Hip replacement, Hip replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Posted 6 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total Hip Arthroplasties (THA), it was determined that the investigators could simultaneously capture in vivo sound and motion of the femoral head within the acetabular cup during weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP), metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA. This was the first study to apply sound analysis as an impulse excitation technique for testing hip conditions and for measuring femoral head sliding in the acetabular component of human hip joints by acoustic means. Unfortunately, no studies have been conducted to compare the in vivo kinematics and sound for subjects implanted using various surgical approaches. It could be hypothesized that subjects having various surgical approaches could lead to an increase or reduction of in vivo hip separation. Therefore, the objective of this study is to analyze a total of 30 subjects implanted with either an anterior (10 patients), anterior-lateral (10 patients), or posterior-lateral (10 patients) surgical approach to determine if any of these surgical approaches leads to less or more in vivo hip separation. All subjects will be analyzed under in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THA using direct-anterior surgical approach | – | Radiation: Fluoroscopy surveillance of patients while walkingPatients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking. |
| THA using anterior-lateral approach | – | Radiation: Fluoroscopy surveillance of patients while walkingPatients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking. |
| THA using posterior-lateral approach | – | Radiation: Fluoroscopy surveillance of patients while walkingPatients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with a direct-anterior surgical approach will be provided by Dr. William Barrett of Valley Orthopedic Associates in Renton, WA. Patients implanted with an anterior-lateral surgical approach will be provided by Dr. of Steven J. MacDonald of the London Health Sciences Center, London, Ontario. Patients implanted with a posterior-lateral approach will be provided by Dr. David F. Dalury of Towson Orthopaedic Associates, Inc. in Towson, MD.
Key inclusion criteria (6 listed)
- Post-operative clinical evaluation judged successful using Harris Hip Scoring (HHS) system (HHS>90)
- Body weight less than 270 lbs
- No evidence of post-operative hip subluxation or dislocation
- Do not walk with detectable limp
- Be able to actively abduct their operated hip against gravity without difficulty
Key exclusion criteria (3 listed)
- Pregnant, lactating or females not using reliable form of birth control
- Patients that do not meet study requirements
- Patients unwilling to sign Informed Consent or HIPAA forms
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 |
|---|---|---|
| Fluoroscopy surveillance of patients while walkingAlso: DePuy Orthopaedics hip implantWhile each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking. | Radiation | THA using anterior-lateral approach, THA using direct-anterior surgical approach, THA using posterior-lateral approach |
Primary outcome
Kinematics - Swing Phase Separation
Time frame: 6 months post-operatively
Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.
Kinematics - Stance Phase Separation
Time frame: 6 months post-operative
Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.
Kinematics - Overall Separation
Time frame: 6 months post-operative
Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- 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.
Richard D Komistek, Ph D principal investigator
The University of Tennessee
Adrija Sharma, Ph D principal investigator
The University of Tennessee
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Injuries, run by The University of Tennessee, Knoxville at 3 sites in 2 countries.
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 6 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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?
Yes. Results are posted in the registry (first posted 6 Nov 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?
Kinematics - Swing Phase Separation (time frame: 6 months post-operatively). The study lists 3 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 10 Oct 2019.