Early Perioperative Quality Of Recovery After Hip and Kne... | NCT06107296

Studies
Early Perioperative Quality Of Recovery After Hip and Knee Arthroplasty: a Retrospective Comparative Cohort Study

NCT06107296

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Oct 30, 2023Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Arthroplasty, Hip Replacement
Arthroplasty, Knee Replacement

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Feb 2024Estimated

Completion Date

Feb 27, 2024Estimated

First Submitted Date

Oct 24, 2023

First Submission Date that Met QC Criteria

Oct 24, 2023

First Posted Date

Oct 30, 2023Actual

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

Oct 24, 2023

Last Update Posted Date

Oct 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hip and knee replacements are indicated to improve long-term quality of life and pain. These long-term results may depend on the quality of the initial postoperative recovery.

However, early postoperative health status after total hip arthroplasty (THA) and total knee arthroplasty (TKA) is not accurately described. Through this retrospective study, the investigators wanted to describe the perioperative state of health monitored using the QoR-15 questionnaire for THA and TKA patients from the perioperative moment to postoperative day 28.

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

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean QoR-15 score at the preoperative period and postoperative days 1, 3, 14 and 28	Perioperative health status monitored using the QoR-15 questionnaire for THA and TKA patients from perioperative time to postoperative day 28	At the preoperative period and postoperative days 1, 3, 14 and 28

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient (age ≥ 18 years)
Having benefited from an ATG or ATH at Strasbourg University Hospital between March 1, 2020 and December 31, 2022
Tracked with QoR-15 score
Patient not opposing the reuse of his data for scientific research purposes

Exclusion Criteria:

Refusal to participate in the study
Patient admitted to THA for a hip fracture
Patient admitted for multiple THA or TKA

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

Adult patient (age ≥ 18 years) Having benefited from an ATG or ATH at Strasbourg University Hospital between March 1, 2020 and December 31, 2022

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eric NOLL, MD, PhD	Contact	33 3 88 12 70 76		eric.noll@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France