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Pelvic Alignment Level (PAL) Instrument Evaluation (PAL)

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ClinicalTrials.gov Identifier: NCT01312428
Recruitment Status : Terminated (Lagging enrollment)
First Posted : March 10, 2011
Results First Posted : August 28, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthroplasty, Replacement, Hip
Interventions Device: Pelvic Alignment Level (PAL) Instrument
Device: No Pelvic Alignment Level (PAL) Instrument
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PAL (Pelvic Alignment Level) No PAL (No Pelvic Alignment Level)
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 3 4
Completed 0 0
Not Completed 3 4
Reason Not Completed
Study Termination             3             4
Arm/Group Title PAL (Pelvic Alignment Level) No PAL (No Pelvic Alignment Level) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 3 4 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 7 participants
65  (12.9) 65.9  (4.1) 65.5  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
Female
2
  66.7%
1
  25.0%
3
  42.9%
Male
1
  33.3%
3
  75.0%
4
  57.1%
1.Primary Outcome
Title To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.
Hide Description [Not Specified]
Time Frame 6 week follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early, therefore, primary or secondary measures were not assessed.
Arm/Group Title PAL (Pelvic Alignment Level) No PAL (No Pelvic Alignment Level)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument.
Hide Description [Not Specified]
Time Frame 6 week follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early, therefore, primary or secondary measures were not assessed.
Arm/Group Title PAL (Pelvic Alignment Level) No PAL (No Pelvic Alignment Level)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title PAL (Pelvic Alignment Level) No PAL (No Pelvic Alignment Level)
Hide Arm/Group Description

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.

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.

All-Cause Mortality
PAL (Pelvic Alignment Level) No PAL (No Pelvic Alignment Level)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PAL (Pelvic Alignment Level) No PAL (No Pelvic Alignment Level)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/4 (0.00%)    
Injury, poisoning and procedural complications     
Operative Site *  1/3 (33.33%)  2 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PAL (Pelvic Alignment Level) No PAL (No Pelvic Alignment Level)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/4 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Director of Clinical Research
Organization: Stryker Orthopedics
Phone: 201-831-5401
Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01312428     History of Changes
Other Study ID Numbers: 64
First Submitted: March 8, 2011
First Posted: March 10, 2011
Results First Submitted: August 15, 2014
Results First Posted: August 28, 2014
Last Update Posted: November 17, 2017