N/A
N=30
THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches
Hip Injuries
Bottom Line
View on ClinicalTrials.gov: NCT01833481 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Kinematics - Swing Phase Separation — 0.9; 0.6; 1.0 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Fluoroscopy surveillance of patients while walking (Radiation)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kinematics - Swing Phase Separation |
0.9; 0.6; 1.0 | — |
| PRIMARY Kinematics - Stance Phase Separation |
0.9; 0.8; 1.0 | — |
| PRIMARY Kinematics - Overall Separation |
1.1; 0.8; 1.2 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01833481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.