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LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study (LFIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00510458
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Arthroplasty, Replacement, Hip
Intervention: Device: LFIT™ Femoral Heads With X3® Insert

  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
89 patients/96 hips - 15 patients/18 hips censored = 74 patients/78 hips

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (hips)

Reporting Groups
  Description
LFIT™Femoral Heads With X3® Insert LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement

Participant Flow:   Overall Study
    LFIT™Femoral Heads With X3® Insert
Participants Units (hips)
STARTED   74   78 
COMPLETED   27   27 
NOT COMPLETED   47    
5 year not evaluable/missed                21                 
Death                1                 
Terminated                14                 
Lost to Follow-up                6                 
Withdrawal by Subject                3                 
Revision                2                 



  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
LFIT™Femoral Heads With X3® Insert LFIT™ Femoral Heads With X3® Insert: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement

Baseline Measures
   LFIT™Femoral Heads With X3® Insert 
Overall Participants Analyzed 
[Units: Participants]
 74 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 61.48  (10.37) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      27  36.5% 
Male      47  63.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   74 


  Outcome Measures

1.  Primary:   Linear Wear Rate   [ Time Frame: 5 Years Post-Surgery ]

2.  Secondary:   Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits   [ Time Frame: preoperative, 1, 3, and 5 years ]

3.  Secondary:   Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits   [ Time Frame: preop, 1, 3, and 5 Years ]

4.  Secondary:   Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.   [ Time Frame: preoperative, 1, 3, and 5 Years ]

5.  Secondary:   Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.   [ Time Frame: preop, 1, 3, and 5 Years ]

6.  Secondary:   Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative   [ Time Frame: preoperative, 1, 3, and 5 Years ]

7.  Secondary:   Number of Hips That Dislocated   [ Time Frame: 3 and 5 years ]

8.  Secondary:   Number of Hips Evaluated as Radiographically Unstable   [ Time Frame: 1, 3, 5 years ]

9.  Secondary:   Percentage of Cases That Did Not Have Any Component Revised   [ Time Frame: 5 years ]


  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
No text entered.


  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, Clinical Operations
Organization: Stryker Orthopaedics
phone: 201-831-5401
e-mail: ellen.axelson@stryker.com



Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00510458     History of Changes
Other Study ID Numbers: 63
First Submitted: August 1, 2007
First Posted: August 2, 2007
Results First Submitted: December 1, 2017
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018