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

NCT01379118 | Completed DMC

• 1 other identifier: 5110158
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Joint Disease; Osteoarthritis; Knee Injury, Trauma; Connective Tissue Disorder; Pain; Loss of Function

Keywords

Total knee replacement

Outcome Measures

Primary Outcomes (1)

• Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patient before and after surgery

  To determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures. Clinical measures in the form of the Knee Society Score and the WOMAC Score will be obtained from patients.

  36 months

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients that are healthy and patients that need a unilateral total knee replacement.

You may qualify if:

• Healthy
• needs unilateral total knee replacement

You may not qualify if:

• Active infection
• Autoimmune disease/ parkinson's disease
• HIV
• psychosocial disorders that would preclude accurate evaluation or substance abuse
• allergic to
• pregnant
• active malignancy

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Healthcare, Deptartment of Orthopaedic Surgery

San Bernardino, California, 92408, United States

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Knee Injuries; Wounds and Injuries; Connective Tissue Diseases; Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Leg Injuries; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gary D. Botimer, M.D.

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. and Chairman

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 23, 2011
• Study Start: July 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

US (1)