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

Completed

• Conditions: Hip Injuries
• Interventions: Device: DePuy Synthes total hip arthroplasty; Radiation: Computer tomography; Radiation: Fluoroscopy surveillance

• Registration Number: NCT02682602
• Lead Sponsor: The University of Tennessee, Knoxville

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-15
• Study Start: 2016-04
• Primary Completion: 2018-12
• Study Completion: 2019-03
• Results First Submitted: 2019-09-23
• Results First Submitted QC: 2019-10-23
• Status Verified: 2019-11
• Results First Posted: 2019-11-08
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diseased Hip	Fluoroscopy surveillance	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.
Normal Hip	Fluoroscopy surveillance	Subjects will have a normal hip.
Implanted Group	DePuy Synthes total hip arthroplasty	All subjects from the Diseased Hip group were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA
Normal Hip	Computer tomography	Subjects will have a normal hip.
Implanted Group	Fluoroscopy surveillance	All subjects from the Diseased Hip group were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA
Diseased Hip	Computer tomography	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.

Primary Outcome Measures

Name	Time	Method
Magnitude of Hip Separation During Primary Heel Strike	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	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	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	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.

Trial Locations

Locations (3)

Abercrombie Radiology; 🇺🇸 Knoxville, Tennessee, United States

The University of Tennessee; 🇺🇸 Knoxville, Tennessee, United States

Northside Hospital- Forsyth , GA 30041; 🇺🇸 Cumming, Georgia, United States