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OpenTrials
Completed

NCT Number: NCT01989117

Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Ambroise Pare

Boulogne-Billancourt, 92100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: At one month postoperatively

Secondary outcomes

  1. Pain self-assessment during the first postoperative month on Visual analog scale (VAS)

    Time frame: Twice daily during the first postoperative month

  2. Functional assessment of the knee with International Knee Society (IKS) score

    Time frame: At six months postoperatively

  3. Functional assessment of the knee with International Knee Society (IKS) score

    Time frame: At one year postoperatively

Sponsors and collaborators

Lead sponsor

Hospital Ambroise Paré Paris

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2013
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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