Prospective Non-randomized Comparative Study Evaluating the Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement in Osteoarthritis Indication

Hospital Ambroise Paré Paris1 site in 1 country70 target enrollmentNovember 2013

ConditionsTotal Knee Replacement Osteoarthritis of the Knee Preoperative Osteopathic Care

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Total Knee Replacement
Sponsor: Hospital Ambroise Paré Paris
Enrollment: 70
Locations: 1
Primary Endpoint: Self-assessment of knee pain on Visual Analog Scale (VAS)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Osteopathy is an alternative healthcare that seems effective in relieving the pain of patients. The main purpose of this study is to evaluate the efficacy of preoperative osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The secondary objectives are to assess pain during the first postoperative month on a VAS and knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy will decrease postoperative pain and increase knee function.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

December 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hospital Ambroise Paré Paris

Responsible Party

Principal Investigator

Shahnaz Klouche, MD

Physician Responsible of Clinical Research

Hospital Ambroise Paré Paris

Eligibility Criteria

Inclusion Criteria

•Primary total knee arthroplasty (TKA)
•For osteoarthritis of the knee
•Without surgical history on the operated knee

Exclusion Criteria

•Previous surgery on the operated knee
•Bilateral TKA
•Patient refusal

Outcomes

Primary Outcomes

Self-assessment of knee pain on Visual Analog Scale (VAS)

Time Frame: At one month postoperatively

Secondary Outcomes

Pain self-assessment during the first postoperative month on Visual analog scale (VAS)(Twice daily during the first postoperative month)
Functional assessment of the knee with International Knee Society (IKS) score(At one year postoperatively)