Trial Outcomes & Findings for Pelvic Alignment Level (PAL) Instrument Evaluation (NCT NCT01312428)
NCT ID: NCT01312428
Last Updated: 2017-11-17
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
6 week follow-up
Results posted on
2017-11-17
Participant Flow
Participant milestones
| Measure |
PAL (Pelvic Alignment Level)
The cases randomized into the "PAL Group" will have total hip replacement surgery performed utilizing the PAL instrument.
Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument.
|
No PAL (No Pelvic Alignment Level)
The cases randomized into the "No PAL Group" will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.
Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
PAL (Pelvic Alignment Level)
The cases randomized into the "PAL Group" will have total hip replacement surgery performed utilizing the PAL instrument.
Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument.
|
No PAL (No Pelvic Alignment Level)
The cases randomized into the "No PAL Group" will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.
Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument.
|
|---|---|---|
|
Overall Study
Study Termination
|
3
|
4
|
Baseline Characteristics
Pelvic Alignment Level (PAL) Instrument Evaluation
Baseline characteristics by cohort
| Measure |
PAL (Pelvic Alignment Level)
n=3 Participants
The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.
Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument.
|
No PAL (No Pelvic Alignment Level)
n=4 Participants
The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.
Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12.9 • n=39 Participants
|
65.9 years
STANDARD_DEVIATION 4.1 • n=41 Participants
|
65.5 years
STANDARD_DEVIATION 8.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 week follow-upPopulation: The study was terminated early, therefore, primary or secondary measures were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 week follow-upPopulation: The study was terminated early, therefore, primary or secondary measures were not assessed.
Outcome measures
Outcome data not reported
Adverse Events
PAL (Pelvic Alignment Level)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
No PAL (No Pelvic Alignment Level)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PAL (Pelvic Alignment Level)
n=3 participants at risk
The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.
Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument.
|
No PAL (No Pelvic Alignment Level)
n=4 participants at risk
The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.
Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Operative Site
|
33.3%
1/3 • Number of events 2 • 6 weeks
Industry Standard Adverse Event (AE) terms (e.g. MedDRA) were not used for AE data collection. Specific AE terms were not used for all AEs collected.
|
0.00%
0/4 • 6 weeks
Industry Standard Adverse Event (AE) terms (e.g. MedDRA) were not used for AE data collection. Specific AE terms were not used for all AEs collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee To publish, exhibit or lecture, the manuscript, exhibit or speech must be provided to Stryker at least 60 days prior to submission for publication or presentation. The Investigator must receive consent from Stryker prior to publication, exhibition, or disclosure of scientific and clinical data. This review by Stryker is not intended to curtail distribution of scientific and clinical data, but to identify and edit any company confidential material and/or violations of FDA and FTC regulations.
- Publication restrictions are in place
Restriction type: OTHER