Arthroplasty, Hip ReplacementEARLY-QoRNCT06107296
Early Perioperative Quality Of Recovery After Hip and Knee Arthroplasty: a Retrospective Comparative Cohort Study
An observational study of Arthroplasty, Hip Replacement and Arthroplasty, Knee Replacement, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Hip Replacement, Arthroplasty, Knee Replacement
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 27 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the study
- Patient admitted to THA for a hip fracture
- Patient admitted for multiple THA or TKA
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France
Strasbourg, 67091
Eric NOLL, MD, PhD, 33 3 88 12 70 76, eric.noll@chru-strasbourg.fr
Thomas PERRIN, 33 3 88 12 70 76, thomas.perrin@chru-strasbourg.fr
About this study
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.
- Keywords
- Arthroplasty, Hip Replacement, Knee Replacement, QoR-15 questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the preoperative period and postoperative days 1, 3, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Mar 2023
- Primary completionFeb 2024 (estimated)
- Study completion27 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Hip ReplacementStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107296
- Sponsor's protocol ID
- 8898
- Acronym
- EARLY-QoR
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Perioperative Quality Of Recovery After Hip and Knee Arthroplasty: a Retrospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT06107296
- Acronym / sponsor ID
- EARLY-QoR / 8898
- Keywords
- Arthroplasty, Hip Replacement, Knee Replacement, QoR-15 questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- 27 Feb 2024 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Patient admitted to THA for a hip fracture
- Patient admitted for multiple THA or TKA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean QoR-15 score at the preoperative period and postoperative days 1, 3, 14 and 28
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Hip Replacement and Arthroplasty, Knee Replacement, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric NOLL, MD, PhD (33 3 88 12 70 76, eric.noll@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean QoR-15 score at the preoperative period and postoperative days 1, 3, 14 and 28 (time frame: At the preoperative period and postoperative days 1, 3, 14 and 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.