NCT06107296

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2024

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 24, 2023

Last Update Submit

October 24, 2023

Conditions

Arthroplasty, Hip ReplacementArthroplasty, Knee Replacement

Keywords

ArthroplastyHip ReplacementKnee ReplacementQoR-15 questionnaire

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Eric NOLL, MD, PhD

CONTACT

33 3 88 12 70 76eric.noll@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

March 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 27, 2024

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations

FR(1)