Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement

Total Knee Replacement Clinical Trial

Official title:

A Randomised Controlled Study To Compare the Effects of a Standard Therapy Protocol With a 12-week Peri-Operative Program of Kneehab XP Compared to a Control Treatment in Patients Undergoing Total Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548040
• Other study ID #: Pro00012744
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: March 16, 2018
• Start date: March 2012
• Est. completion date: October 2016

Study information

• Verified date: March 2018
• Source: Theragen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective, randomized, double-blind sham study of TKA patients who receive a standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative treatment program plus a sham device.

Description:

The study is a double-blind randomized controlled clinical trial of approximately 118 patients (males and females) who are at least 40 years of age, who are scheduled for Total Knee Arthroplasty (TKA) surgery will be randomized into 1) a treatment group who receive Kneehab XP and a standard rehabilitation program and 2) a control group who receive only a sham device and a standard rehabilitation program. Patients are tracked for measures of function, pain, quality of life, physical performance and acceptable states status at 6 weeks and 1 week before surgery and 3, 6, 12, and 52 weeks following surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Individuals who are scheduled for Total Knee Replacement surgery with the Smith and Nephew Visionaire prosthesis and the anterior surgical approach.

• Individuals who are at least 40 years of age.

• Individuals with a body mass index (BMI) <40 kg/ m2

• Individuals who are walking independently with or without assistive devices.

• Individuals with a Short Performance Battery Score greater than 7.

• Must be able and willing to complete all study assessments and to be followed for the full course of the study.

• Must be able to read, write and follow instructions in English.

• Must be able and willing to provide informed consent.

• Must be willing and able to attend the additional pre-operative assessment.

Exclusion Criteria:

• Individuals with a history of foot and/or ankle pathology.

• Individuals with a history of tibial or femoral fractures.

• Individuals with a history of any underlying neurological conditions.

• Individuals with physical conditions which would make them unable to perform study procedures.

• Individuals with a total hip replacement.

• Individuals undergoing revision TKA of the same operated leg.

• Individuals who are pregnant.

• Individuals diagnosed with a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site.

• Individuals with an active implanted medical device (i.e. pacemaker, pump)

• Individuals with a history of stroke

• Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.)

• Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis).

• Individuals with muscle diseases (i.e. muscular dystrophy)

• Individuals with visible skin injury or disease on their legs.

• Individuals who have been committed to an institution by virtue of an order issued either by the courts or by an authority.

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Device:
• 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
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.

Locations

Country	Name	City	State
United States	Hawkins Foundation	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Theragen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Therapy Sessions	Change in patient functional measures and number of therapy sessions required.	1 wk pre-operatively, 3,6,12,52 week post operatively
Other	Questionnaires	Change in scores in patient outcome measures, functional measures and physical performance measures	1 wk pre-operatively, 3,6,12,52 week post operatively
Other	Range of Motion	Change in scores of functional and physical performance scores	1 wk pre-operatively, 3,6,12,52 week post operatively
Other	Timed to Get up and go	Change in scores of physical performance measures	1 wk pre-operatively, 3,6,12,52 week post operatively
Other	Stair Climb Test	Change in scores of physical performance measures	1 wk pre-operatively, 3,6,12,52 week post operatively
Other	Visual Analogue Scales (VAS)	Pain change score in VAS from baseline to week 6 post-surgery	1 wk pre-operatively,3,6,12 and 52 post operatively
Primary	Isometric Strength Test	To determine the efficacy of Kneehab XP in promoting early quadriceps strength improvement (measured as the difference between the baseline time point and the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Isometric strength was measured using a Biodex Isokinetic Dynamometer machine on patients seated and secured to a chair and who performed 3 maximal voluntary contractions (MVC) for which the maximal torque is measured and a mean taken of 3 consecutive MVC's.	measured at the 6 week post-operative time point
Secondary	Percentage of Patients With Positive PASS	To determine whether Kneehab XP leads to earlier recovery (measured at the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Patient Acceptable Symptom State (PASS) is a yes/no answer to a specifically stated question about the patients satisfaction with their state. For clarity, Positive PASS implies that the answer that is given is Positive i.e. Yes	measured at the 6 week post-operative time point