Active Versus Passive Motion Device Following Knee Replacement Surgery

NCT02339831 | Completed Results

• 1 other identifier: WFCAMCPM1
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine how well an active motion device, Camoped, works compared to a continuous passive motion device, CPM, for rehabilitation after partial or total knee replacement. It is hypothesized that the Camoped active motion device will provide outcomes equal to or superior than the CPM. Patients undergoing either partial or total knee replacement will be given the opportunity to participate. If they elect to participate, preoperative data will be collected including demographics, measures of strength, balance and knee bending, as well as surveys regarding current physical and mental health, as well as knee function. After surgery, patients will be randomly selected to receive either the Camoped or the CPM for use during their rehabilitation. After discharge, participants will be asked to maintain a daily diary tracking their use of the assigned device, as well as their daily pain levels. At a visit 4 weeks after surgery, participants will be asked to complete a series of surveys pertaining to their health and knee function, as well as to perform tests of strength, balance and knee bending. These results will be used to determine if one device produces superior rehabilitation results following total or partial knee replacement surgery.

Conditions

Knee Arthroplasty

Keywords

Knee; Arthroplasty; CPM; Camoped; Active vs Passive Motion Device

Outcome Measures

Primary Outcomes (5)

• Early Functional Outcome Strength

  Quadriceps strength measurements using a hand held dynamometer

  4-6 weeks post-op

• Early Functional Outcome by Sit to Stand Test

  Sit-to-Stand test: After one demonstration of the sit-to-stand test, standing up from a seated position without support, two tests were timed and the better value recorded. Patient was asked to sit with back against chair and told to stand up without using any support. Arms were suggested to be folded in front of chest. Time started with recorded said "Go".

  4-6 weeks post-op

• Early Functional Outcome Proprioception

  Biodex Balance Machine Score. The system consists of a multiaxial standing platform with a maximum tilt of 20 degrees. All participants were tested on level 8, and a balance index was calculated using the time and deviation (in degrees) on the platform relative to a neutral position. The normal range for adults 54-71 is 1.79 - 3.35. Lower values indicate better/greater stability.

  4-6 weeks post-op

• Early Function Outcome Kinesthesia

  Kinesthesia was measured by recording the angle of the flexed knee and documenting how close the patient was able to reproduce the angle with closed eyes. The differences were recorded in degrees using an 8-inch goniometer.

  4-6 weeks post op

• Early Functional Outcome Knee Flexion

  Knee-flexion was measured using an 8-inch goniometer.

  4-6 weeks post op

Secondary Outcomes (4)

• General Mental Orthopaedic Outcome Measures

  4-6 weeks post-op

• General Activity Orthopaedic Outcome Measures

  4-6 weeks post-op

• General Functional Orthopaedic Outcome Measures

  4-6 weeks post-op

• General Pain

  4-6 weeks post-op

Study Arms (2)

active motion device

ACTIVE COMPARATOR

An active motion device (CAM) known as a CAMOPED was given after surgery. The device was used for 3 sessions of 20 minutes for 3 weeks.

Device: CAMOPED

CPM passive motion device

ACTIVE COMPARATOR

A continuous passive motion device (CPM) given after surgery. The device bends and moved the knee passively. It was used for 4 hours daily for 3 weeks.

Device: CPM passive motion device

Interventions

CAMOPED DEVICE

Camoped given after surgery

active motion device

CPM passive motion device DEVICE

passive motion device given after surgery

CPM passive motion device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Undergoing unilateral knee replacement
• If female, not pregnant
• Agree to participate in the follow-up appointment
• Understand and sign the informed consent form

You may not qualify if:

• Bilateral UKA or TKA planned
• Cannot use non-operated leg post-operatively to propel active motion splint, caused by neurological or muscular diseases such as complete or incomplete paralysis or other causes of weakness with an inability to bend or extend knee
• Loss of sensation of/in? operated or non-operated leg
• Received investigational articles \<30 days prior to enrollment or was currently receiving investigational products or devices.
• Below or above knee amputations of non-operated leg
• Below knee amputation of operated side
• Chronic pain syndrome with inability to walk and/or use active or passive motion device post-operatively
• Patients taking chronic narcotics and/or are taking more than 10mg codeine per day, or any Hydrocodone, more than 200 mg of tramadol, or any other narcotics prescribed for moderate to severe pain
• Patients involved in pain clinics for chronic pain, or pain that is not related to the knee
• Diagnosis of knee disorder other than osteoarthritis, post-traumatic osteoarthritis, gout, pseudo gout
• Inability to walk due to disorders unrelated to the knee (e.g., hip disorders, spinal stenosis, paralysis, hemiparalysis)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The New England Baptist Hospital: collaborator

Related Publications (5)

• Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

  PMID: 15866968 BACKGROUND

• Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD004260. doi: 10.1002/14651858.CD004260.pub2.

  PMID: 20238330 BACKGROUND

• Arnold BL, Schmitz RJ. Examination of balance measures produced by the biodex stability system. J Athl Train. 1998 Oct;33(4):323-7.

  PMID: 16558529 BACKGROUND

• Gstoettner M, Raschner C, Dirnberger E, Leimser H, Krismer M. Preoperative proprioceptive training in patients with total knee arthroplasty. Knee. 2011 Aug;18(4):265-70. doi: 10.1016/j.knee.2010.05.012. Epub 2010 Aug 30.

  PMID: 20801047 BACKGROUND

• Wada M, Kawahara H, Shimada S, Miyazaki T, Baba H. Joint proprioception before and after total knee arthroplasty. Clin Orthop Relat Res. 2002 Oct;(403):161-7. doi: 10.1097/00003086-200210000-00024.

  PMID: 12360022 BACKGROUND

Limitations and Caveats

We ran into an unexpected problem in recruiting patients for this study. Many did not want to participate in this study, as they did not want to use the passive device and were not willing to use it 4 hours each day.

Results Point of Contact

• Title: Wolfgang Fitz MD
• Organization: Brigham and Women's Hospital

wfitz@partners.org

617-732-9500

Study Officials

• Wolfgang Fitz, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Orthopaedic Surgeon

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 16, 2015
• Study Start: March 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 20, 2017
• Results First Posted: March 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share