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Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT01548040
Recruitment Status : Completed
First Posted : March 8, 2012
Results First Posted : March 19, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Theragen Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Total Knee Replacement
Interventions: Device: Kneehab XP
Device: Quadriceps TENS

  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
No text entered.

Reporting Groups
  Description
Quadriceps NMES Using Kneehab XP

All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation

Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively

Quadriceps TENS

The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation

quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.


Participant Flow:   Overall Study
    Quadriceps NMES Using Kneehab XP   Quadriceps TENS
STARTED   56   55 
COMPLETED   43   45 
NOT COMPLETED   13   10 



  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
Quadriceps NMES Using Kneehab XP

All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation

Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively

Quadriceps TENS

The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation

quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.

Total Total of all reporting groups

Baseline Measures
   Quadriceps NMES Using Kneehab XP   Quadriceps TENS   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   55   111 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   56   55   111 
   65.1  (8.23)   64.5  (10.23)   64.8  (9.24) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   56   55   111 
Female      32  57.1%      32  58.2%      64  57.7% 
Male      24  42.9%      23  41.8%      47  42.3% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   0   0   0 
         0 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed   56   55   111 
United States   56   55   111 
Smoking Status 
[Units: Participants]
Count of Participants
     
Participants Analyzed   56   55   111 
Current      3   5.4%      1   1.8%      4   3.6% 
Non      36  64.3%      34  61.8%      70  63.1% 
Ex      17  30.4%      20  36.4%      37  33.3% 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
     
Participants Analyzed   56   55   111 
   30.0  (5.03)   29.4  (5.23)   29.7  (5.11) 


  Outcome Measures

1.  Primary:   Isometric Strength Test   [ Time Frame: measured at the 6 week post-operative time point ]

2.  Secondary:   Percentage of Patients With Positive PASS   [ Time Frame: measured at the 6 week post-operative time point ]

3.  Other Pre-specified:   Physical Therapy Sessions   [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Other Pre-specified:   Questionnaires   [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Range of Motion   [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Timed to Get up and go   [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Stair Climb Test   [ Time Frame: 1 wk pre-operatively, 3,6,12,52 week post operatively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Visual Analogue Scales (VAS)   [ Time Frame: 1 wk pre-operatively,3,6,12 and 52 post operatively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 NOT 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.


Results Point of Contact:  
Name/Title: Richard Pearce
Organization: Theragen Inc.
phone: 901 634 0544
e-mail: richard.pearce@theragen.com



Responsible Party: Theragen Inc.
ClinicalTrials.gov Identifier: NCT01548040     History of Changes
Other Study ID Numbers: Pro00012744
First Submitted: February 16, 2012
First Posted: March 8, 2012
Results First Submitted: December 5, 2017
Results First Posted: March 19, 2018
Last Update Posted: April 11, 2018