Trial Outcomes & Findings for THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips (NCT NCT02682602)
NCT ID: NCT02682602
Last Updated: 2019-11-25
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
21 participants
Primary outcome timeframe
Approximately 2 years postoperatively.
Results posted on
2019-11-25
Participant Flow
Participant milestones
| Measure |
Diseased/Implanted Hip
Subjects with 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
Subjects with a normal hip.
|
|---|---|---|
|
Pre-operative Diseased & Normal Hips
STARTED
|
11
|
10
|
|
Pre-operative Diseased & Normal Hips
COMPLETED
|
10
|
10
|
|
Pre-operative Diseased & Normal Hips
NOT COMPLETED
|
1
|
0
|
|
Post-operative Fluoroscopy for Implanted
STARTED
|
10
|
0
|
|
Post-operative Fluoroscopy for Implanted
COMPLETED
|
7
|
0
|
|
Post-operative Fluoroscopy for Implanted
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Diseased/Implanted Hip
Subjects with 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
Subjects with a normal hip.
|
|---|---|---|
|
Pre-operative Diseased & Normal Hips
Unusable images
|
1
|
0
|
|
Post-operative Fluoroscopy for Implanted
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
Baseline characteristics by cohort
| Measure |
Diseased/Implanted Hip
n=11 Participants
Subjects with 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
n=10 Participants
Subjects with a normal hip.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants • One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
|
0 Participants
n=10 Participants • One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
|
0 Participants
n=20 Participants • One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=10 Participants • One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
|
5 Participants
n=10 Participants • One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
|
11 Participants
n=20 Participants • One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
|
|
Age, Categorical
>=65 years
|
4 Participants
n=10 Participants • One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
|
5 Participants
n=10 Participants • One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
|
9 Participants
n=20 Participants • One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol.
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants • One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. Participation in pre-operative fluoroscopy counts toward total study enrollment.
|
5 Participants
n=10 Participants • One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. Participation in pre-operative fluoroscopy counts toward total study enrollment.
|
9 Participants
n=20 Participants • One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. Participation in pre-operative fluoroscopy counts toward total study enrollment.
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants • One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. Participation in pre-operative fluoroscopy counts toward total study enrollment.
|
5 Participants
n=10 Participants • One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. Participation in pre-operative fluoroscopy counts toward total study enrollment.
|
11 Participants
n=20 Participants • One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. Participation in pre-operative fluoroscopy counts toward total study enrollment.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants • One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. This subject's participation in pre-operative data collection counts toward study enrollment.
|
10 participants
n=10 Participants • One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. This subject's participation in pre-operative data collection counts toward study enrollment.
|
17 participants
n=20 Participants • One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. This subject's participation in pre-operative data collection counts toward study enrollment.
|
PRIMARY outcome
Timeframe: Approximately 2 years postoperatively.Population: All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
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.
Outcome measures
| Measure |
Diseased Hip (Baseline)
n=10 Participants
Subjects with 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
n=10 Participants
Subjects with a normal hip.
|
Implanted Hip
n=7 Participants
Subjects from diseased hip group who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
|
|---|---|---|---|
|
Magnitude of Hip Separation During Primary Heel Strike
|
-0.591 mm
Standard Deviation 1.582
|
0.096 mm
Standard Deviation 1.369
|
0.558 mm
Standard Deviation 0.326
|
PRIMARY outcome
Timeframe: Approximately 2 years postoperatively.Population: All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
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.
Outcome measures
| Measure |
Diseased Hip (Baseline)
n=10 Participants
Subjects with 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
n=10 Participants
Subjects with a normal hip.
|
Implanted Hip
n=7 Participants
Subjects from diseased hip group who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
|
|---|---|---|---|
|
Magnitude of Hip Separation During Contra-lateral Toe Off
|
-1.051 mm
Standard Deviation 1.235
|
-0.065 mm
Standard Deviation 0.986
|
1.593 mm
Standard Deviation 0.307
|
PRIMARY outcome
Timeframe: Approximately 2 years postoperatively.Population: All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
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.
Outcome measures
| Measure |
Diseased Hip (Baseline)
n=10 Participants
Subjects with 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
n=10 Participants
Subjects with a normal hip.
|
Implanted Hip
n=7 Participants
Subjects from diseased hip group who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
|
|---|---|---|---|
|
Magnitude of Hip Separation During Contra-lateral Heel Strike
|
-1.019 mm
Standard Deviation 1.808
|
-0.344 mm
Standard Deviation 1.518
|
0.566 mm
Standard Deviation 0.188
|
PRIMARY outcome
Timeframe: Approximately 2 years postoperatively.Population: All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
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.
Outcome measures
| Measure |
Diseased Hip (Baseline)
n=10 Participants
Subjects with 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
n=10 Participants
Subjects with a normal hip.
|
Implanted Hip
n=7 Participants
Subjects from diseased hip group who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
|
|---|---|---|---|
|
Magnitude of Hip Separation During Primary Toe Off
|
-0.936 mm
Standard Deviation 1.243
|
-0.143 mm
Standard Deviation 1.305
|
0.512 mm
Standard Deviation 0.149
|
Adverse Events
Diseased Hip
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Hip
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Implanted Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard Komistek, Principal Investigator
University of Tennessee
Phone: 8659742093
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place