Comparison of Clinical Outcomes & Performance of Total Knee Replacement

Status Completed

Clinical Trial Summary

This study is to determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee Society Score and the WOMAC Score will be obtained from patients. Gait data will also be obtained from total knee replacement (TKR) patients at pre-operative and post-operative times. Gait data will be measured on unaffected normal controls as a second baseline.

The hypothesis is that the subjects clinical outcome measures do not accurately reflect gait dependent outcomes amd functional performance of the total knee replacement.

Clinical Trial Description

Patients scheduled to undergo unilateral total knee replacement (TKR) surgery will be the subjects of the study. A control group of Healthy volunteers, will serve as a control group. The control group will be matched as close as possible by age and gender to the TKR group. Both pre and post-operative (3 weeks, 6, 9 and 12 months follow-up) measurements will be performed on the TKR group.

A Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to record body motion, the sensors for the IDEEA device will be placed on the patient and secured with adhesive tape(if not allergic) once the IDEEA device is properly placed on the patient, measuring and calibrating can start.

The patient will be required to perform tasks, walking at a normal pace for approximately 100 feet on a level surface, walk up and down moderate incline ramp, climb stairs 7 to 8 steps, sit and rise from two chairs. Parameters will be measured on each subject, knee flexion angle( walking, stair climbing and sitting), velocity ( walking and stair climbing), Stride length (walking), Energy (walking, stair climbing, and sitting), other parameters will be added as needed. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01379118
Study type	Observational
Source	Loma Linda University
Contact
Status	Completed
Phase	N/A
Start date	July 2012
Completion date	April 2016

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05559255` - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI	N/A
Completed	`NCT04748367` - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care	N/A
Terminated	`NCT04356352` - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain	Phase 2/Phase 3
Completed	`NCT05057988` - Virtual Empowered Relief for Chronic Pain	N/A
Completed	`NCT04466111` - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting	`NCT05868122` - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy	Phase 3
Recruiting	`NCT06206252` - Can Medical Cannabis Affect Opioid Use?
Active, not recruiting	`NCT05006976` - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study	N/A
Completed	`NCT03273114` - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain	N/A
Enrolling by invitation	`NCT06087432` - Is PNF Application Effective on Temporomandibular Dysfunction	N/A
Completed	`NCT05508594` - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001	Phase 2/Phase 3
Recruiting	`NCT03646955` - Partial Breast Versus no Irradiation for Women With Early Breast Cancer	N/A
Active, not recruiting	`NCT03472300` - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed	`NCT03678168` - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries	N/A
Completed	`NCT03931772` - Online Automated Self-Hypnosis Program	N/A
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Completed	`NCT02913027` - Can We Improve the Comfort of Pelvic Exams?	N/A
Terminated	`NCT02181387` - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?	Phase 4
Recruiting	`NCT06032559` - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment	Phase 3
Active, not recruiting	`NCT03613155` - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery — TKR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms