Hip InjuriesNCT02682602

THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips

An observational study of Hip Injuries, run by The University of Tennessee, Knoxville at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Hip Injuries
What is being tested?: DePuy Synthes total hip arthroplasty, Computer tomography and Fluoroscopy surveillance
Type of treatment: Medical device, Surgery or procedure
How many people: 21 participants
Where: 3 sitesUnited States
Study dates: Apr 2016to Mar 2019
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: Subjects with a diseased hip that requires THA. OR Subjects with a normal hip.

Who may be able to join

Subjects will require a THA and will be implanted with either Summit/Pinnacle THA or Corail/Pinnacle THA.
Patients must be at least six months post-operative with no other surgical procedures conducted within the past six months that will prohibit them from performing the study activities.
Patients must be between 40-85 years of age.
Potential subjects will have a body weight of less than 250 lbs.
Participants must have Body Mass Index (BMI) of less than 38.
Potential subjects' THAs should be judged clinically successful with a HHS >90.

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Subjects must have demonstrated no evidence of post-operative hip subluxation or dislocation.
Subjects must not walk with a detectable limp and must be able to actively abduct their operated hip against gravity without difficulty.
Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without assistance.
Patients from the physician's list who do not meet the study requirements will not be considered.
Patients must be willing to sign the Informed Consent (IC)/HIPAA form to participate in the study.
Patients must not have any kind of hip implant.
Subjects must not have had any type of hip surgery or any pathological hip conditions, including osteoarthritis, or hip pain.
Patients must be between the ages of 18 and 65.
Potential subjects will have a body weight of less than 250 lbs.
Participants must have BMI of less than 38.
Pregnant or potentially pregnant females will be excluded from the study. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without aid of any kind or have had any kind of surgical procedure within the past 6 months that would affect his/her ability to perform the study activities.
Patients must be willing to sign the IC and HIPAA forms to participate in the study.
Patients must be between 160cm (5'3) and 193cm (6'4) tall

Who cannot join

Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
Subjects without one of the two types of required hip implants.
Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.
Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.
Subjects with pain, functional deficits, or generalized inflammatory.
Subjects who walk with a detectable limp.

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Subjects who cannot actively abduct their operated hip against gravity without difficulty.
Subjects who are unwilling to sign IC/HIPAA document.
Subjects who have a HHS <90.
Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study
Subjects with any kind of hip implant.
Subjects who have had any past hip surgery, have pathological hip conditions and/or hip pain.
Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.
Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.
Subjects who are unwilling to sign IC/HIPAA document.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Northside Hospital- Forsyth , GA 30041
Cumming, Georgia, 30041
Abercrombie Radiology
Knoxville, Tennessee, 37909
The University of Tennessee
Knoxville, Tennessee, 37996

Other trials in United States

About this study

Official title: In Vivo Determination of Total Hip Arthroplasty (THA) Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips

The objective of this study is to analyze subjects having a normal hip and compare the in vivo kinematics to subjects requiring a total hip arthroplasty (THA) due to having a diseased hip and then later post-operative to their implanted hip. Ten subjects will have a normal hip, ten hips will be diseased, requiring a THA and then those ten diseased hips will be re-analyzed at least six months post-operatively after implantation of a THA.

Conditions: Hip Injuries
Being tested: DePuy Synthes total hip arthroplasty, Computer tomography, Fluoroscopy surveillance
Keywords: total hip arthroplasty
Medical subject headings: Hip Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DePuy Synthes total hip arthroplastyDevice
Also called DePuy Synthes Summit/Pinnacle THA, DePuy Synthes Corail/Pinnacle THA
Computer tomographyRadiation
Computer tomography (CT) scan of the hip for creation of bone models.
Fluoroscopy surveillanceRadiation
Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.

Study groups in NCT02682602
Study group	Role	What they receive
Diseased Hip		Subjects will have a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA. Receives: Radiation: Computer tomography; Radiation: Fluoroscopy surveillance
Normal Hip		Subjects will have a normal hip. Receives: Radiation: Computer tomography; Radiation: Fluoroscopy surveillance
Implanted Group		All subjects from the Diseased Hip group were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA Receives: Device: DePuy Synthes total hip arthroplasty; Radiation: Fluoroscopy surveillance

What is being measured

The primary outcome is the main question the study is designed to answer.

Magnitude of Hip Separation During Primary Heel Strike
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Measured: Approximately 2 years postoperatively.
Magnitude of Hip Separation During Contra-lateral Toe Off
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Measured: Approximately 2 years postoperatively.
Magnitude of Hip Separation During Contra-lateral Heel Strike
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Measured: Approximately 2 years postoperatively.
Magnitude of Hip Separation During Primary Toe Off
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Measured: Approximately 2 years postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Mar 2019

First posted15 Feb 2016 (estimated)
Study startApr 2016
Primary completionDec 2018
Study completionMar 2019

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: Cohort
Time perspective: Cross-sectional
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02682602
Sponsor's protocol ID: 2631FB
Other IDs: IIS-14002
Status last verified: Nov 2019
First submitted: 20 Nov 2015
Last updated: 25 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hip Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vivo Determination of Total Hip Arthroplasty (THA) Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips
ClinicalTrials.gov ID: NCT02682602
Acronym / sponsor ID: 2631FB
Conditions: Hip Injuries
Keywords: total hip arthroplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: The University of Tennessee, KnoxvilleUniversity, hospital or other
Collaborators: DePuy Synthes
Study start: Apr 2016
Primary completion: Dec 2018 (actual)
Study completion: Mar 2019 (actual)
First posted: 15 Feb 2016 (estimated)
Results: Posted 8 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 3

Arm	Type	Receives
Diseased Hip	–	Radiation: Computer tomography, Radiation: Fluoroscopy surveillanceSubjects will have a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
Normal Hip	–	Radiation: Computer tomography, Radiation: Fluoroscopy surveillanceSubjects will have a normal hip.
Implanted Group	–	Device: DePuy Synthes total hip arthroplasty, Radiation: Fluoroscopy surveillanceAll subjects from the Diseased Hip group were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects with a diseased hip that requires THA. OR Subjects with a normal hip.

Key inclusion criteria (20 listed)

Subjects will require a THA and will be implanted with either Summit/Pinnacle THA or Corail/Pinnacle THA.
Patients must be at least six months post-operative with no other surgical procedures conducted within the past six months that will prohibit them from performing the study activities.
Patients must be between 40-85 years of age.
Potential subjects will have a body weight of less than 250 lbs.
Participants must have Body Mass Index (BMI) of less than 38.

Key exclusion criteria (15 listed)

Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
Subjects without one of the two types of required hip implants.
Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.
Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.
Subjects with pain, functional deficits, or generalized inflammatory.

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
DePuy Synthes total hip arthroplastyAlso: DePuy Synthes Summit/Pinnacle THA, DePuy Synthes Corail/Pinnacle THA	Device	Implanted Group
Computer tomographyComputer tomography (CT) scan of the hip for creation of bone models.	Radiation	Diseased Hip, Normal Hip
Fluoroscopy surveillanceFluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.	Radiation	Diseased Hip, Implanted Group, Normal Hip

Primary outcome

Magnitude of Hip Separation During Primary Heel Strike
Time frame: Approximately 2 years postoperatively.
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Magnitude of Hip Separation During Contra-lateral Toe Off
Time frame: Approximately 2 years postoperatively.
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Magnitude of Hip Separation During Contra-lateral Heel Strike
Time frame: Approximately 2 years postoperatively.
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Magnitude of Hip Separation During Primary Toe Off
Time frame: Approximately 2 years postoperatively.
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.

Results and safety

Results posted to the registry on 8 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diseased/Implanted Hip	11	10
Normal Hip	10	10

Primary outcome: Magnitude of Hip Separation During Primary Heel Strike

Time frame: Approximately 2 years postoperatively.. Mean (Standard Deviation). Unit: mm

Measure	Diseased Hip (Baseline) n = 10	Normal Hip n = 10	Implanted Hip n = 7
Value	-0.591 (1.582)	0.096 (1.369)	0.558 (0.326)

Population analysed: All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.

Primary outcome: Magnitude of Hip Separation During Contra-lateral Toe Off

Time frame: Approximately 2 years postoperatively.. Mean (Standard Deviation). Unit: mm

Measure	Diseased Hip (Baseline) n = 10	Normal Hip n = 10	Implanted Hip n = 7
Value	-1.051 (1.235)	-0.065 (0.986)	1.593 (0.307)

Population analysed: All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.

Primary outcome: Magnitude of Hip Separation During Contra-lateral Heel Strike

Time frame: Approximately 2 years postoperatively.. Mean (Standard Deviation). Unit: mm

Measure	Diseased Hip (Baseline) n = 10	Normal Hip n = 10	Implanted Hip n = 7
Value	-1.019 (1.808)	-0.344 (1.518)	0.566 (0.188)

Population analysed: All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.

Primary outcome: Magnitude of Hip Separation During Primary Toe Off

Time frame: Approximately 2 years postoperatively.. Mean (Standard Deviation). Unit: mm

Measure	Diseased Hip (Baseline) n = 10	Normal Hip n = 10	Implanted Hip n = 7
Value	-0.936 (1.243)	-0.143 (1.305)	0.512 (0.149)

Population analysed: All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.

Adverse events

Time frame: approximately 2 years, 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diseased Hip	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Normal Hip	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Implanted Group	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

Related trials for Hip Injuries

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Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
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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 Komistek, Ph. D. principal investigator

The University of Tennessee

3 sites in 1 country: 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 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 20 inclusion and 15 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 25 Nov 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. 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 8 Nov 2019). 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?

Magnitude of Hip Separation During Primary Heel Strike (time frame: Approximately 2 years postoperatively.). The study lists 4 primary outcomes in all. 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 NCT02682602.

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 25 Nov 2019.