Effectiveness of Osteopathy in the Preoperative Treatment... | NCT01989117

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

NCT01989117

Sponsor

Hospital Ambroise Paré Paris

Status

Completed

Last Update Posted

May 2, 2017Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Total Knee Replacement
Osteoarthritis of the Knee
Preoperative Osteopathic Care

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Nov 14, 2013

First Submission Date that Met QC Criteria

Nov 14, 2013

First Posted Date

Nov 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2017

Last Update Posted Date

May 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shahnaz Klouche, MD, Physician Responsible of Clinical Research, Hospital Ambroise Paré ParisPrincipal Investigator

Lead Sponsor

Hospital Ambroise Paré ParisOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-assessment of knee pain on Visual Analog Scale (VAS)		At one month postoperatively

Secondary Outcomes

Measure	Description	Time Frame
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 six months postoperatively

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for primary total knee arthroplasty (TKA) for osteoarthritis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Ambroise Pare		Boulogne-Billancourt		92100	France

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided