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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    PAL (Pelvic Alignment Level)   No PAL (No Pelvic Alignment Level)
STARTED   3   4 
COMPLETED   0   0 
NOT COMPLETED   3   4 
Study Termination                3                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   PAL (Pelvic Alignment Level)   No PAL (No Pelvic Alignment Level)   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   4   7 
Age 
[Units: Years]
Mean (Standard Deviation)
 65  (12.9)   65.9  (4.1)   65.5  (8.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  66.7%      1  25.0%      3  42.9% 
Male      1  33.3%      3  75.0%      4  57.1% 


  Outcome Measures

1.  Primary:   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.   [ Time Frame: 6 week follow-up ]

2.  Secondary:   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.   [ Time Frame: 6 week follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director of Clinical Research
Organization: Stryker Orthopedics
phone: 201-831-5401
e-mail: ellen.axelson@stryker.com



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