Is Partial Knee Replacement as Same-day Surgery Generalizable?

NCT04790591 | Completed

• 1 other identifier: 2020-02000
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

Fast-track/rapid recovery/Enhanced Recovery After Surgery (ERAS) programs have proven both safe and effective in joint replacement surgery, to the degree where same-day surgery have been tested in selected cases. A transition of the minor partial knee replacement (PKR) procedure, compared with the alternative and more commonly used total knee replacement (TKR) for knee osteoarthritis, into a same-day regime seems reasonable. Especially as PKR is reported to have lower risk of short-term complications than does TKR. The aim of this study is to assess efficacy, patient satisfaction and safety outcome measures for PKR when using a same-day surgery protocol in a Swedish healthcare context where ERAS programs nowadays are considered common ground. With no preselection of patients, all PKR cases by one high-volume surgeon will chronologically be scheduled as the first morning case for one consecutive year, and thereby be included in the study. In order for discharge, strict post-surgery criteria will have to be met. The thesis is that the same-day surgery will be both feasible and safe.

Conditions

Same-day Surgery

Keywords

Arthroplasty, PKR, Same-day discharge, Same-day surgery, UKA

Outcome Measures

Primary Outcomes (1)

• Safety - adverse events and/or readmissions

  Number of severe complications that may have had a causal association with the same-day surgery and any readmissions, no matter the cause

  3 months

Secondary Outcomes (2)

• Feasibility - same-day surgery discharge and resources relocated from the inpatient to the outpatient department

  12 hours and 3 months respectively

• Patient-satisfaction

  24 hours

Study Arms (2)

Age <80 yrs. and ASA class <3

ACTIVE COMPARATOR

To follow a same-day surgery protocol when undergoing a partial knee replacement procedure.

Procedure: Same-day surgery

Age ≥80 yrs. and/or ASA class ≥3

ACTIVE COMPARATOR

To follow a same-day surgery protocol when undergoing a partial knee replacement procedure.

Procedure: Same-day surgery

Interventions

Same-day surgery PROCEDURE

To be allowed same-day discharge certain postoperative criteria have to be met. These are categorized into four dimensions - vital parameters, urinary function, bleeding, and mobilization.

Age <80 yrs. and ASA class <3; Age ≥80 yrs. and/or ASA class ≥3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants/patients that will undergo a partial knee replacement (PKR) procedure within one consecutive year by one high-volume surgeon (i.e. no preselection of patients will be made)

You may not qualify if:

• PKR procedures performed by other surgeons
• One-stage bilateral PKR procedures
• PKR procedures not given the first surgery slot of the day

Sponsors & Collaborators

• Region Skane: lead

Study Sites (2)

Skåne University Hospital

Lund, Region Skåne, 221 85, Sweden

Location

Trelleborg Hospital

Trelleborg, Region Skåne, 231 85, Sweden

Location

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Magnus Tveit, MD, PhD

  Region Skane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic consultant, PhD

Model Details: Open clinical trial with a subgroup analysis (One can argue whether this study should be defined as a cohort study or as an open clinical trial. The idea of the study originated from the need to observe/confirm the feasibility and safety aspects of a routine which as of today has become common practice, namely same-day surgery, but as such it may also be categorized as a treatment... Either way, based on the preselection of age and comorbidity often reported in the literature, a two-arm subgroup analysis of the nonselective study participants will be conducted.)

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 10, 2021
• Study Start: February 7, 2019
• Primary Completion: February 14, 2020
• Study Completion: May 18, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)