NCT07840391

Brief Summary

The goal of this observational study is to examine changes in physical activity, sleep quality, knee extension and flexion strength, knee range of motion, and patient-reported outcomes before and after same-day discharge knee arthroplasty (SDD-KA). The study will also investigate whether these changes are associated with each other and with patient satisfaction. As a prespecified secondary aim, researchers will compare these outcomes between patients undergoing medial unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA). The main questions it aims to answer are:

  • How do physical activity, sleep quality, knee extension and flexion strength, knee range of motion, and patient-reported outcomes change following SDD-KA?
  • Are changes in these outcomes associated with each other and with patient satisfaction?
  • Are these outcomes different between patients undergoing medial UKA and TKA? Participants will:
  • Wear an accelerometer to measure physical activity and sleep before surgery, continuously from surgery to 3 months after surgery, and again for 2 weeks at 12 months after surgery
  • Complete questionnaires about knee function, sleep quality, pain, health-related quality of life, and satisfaction with surgery
  • Have knee muscle strength and active knee range of motion assessed before and 12 months after surgery
  • Attend follow-up assessments during the 12-month postoperative period

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
29mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress34%
Aug 2025Feb 2029

Study Start

First participant enrolled

August 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

3.5 years

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

Knee arthroplastyPartial Knee replacementSame-day dischargePatient reported outcomesPhysical activitySleep

Outcome Measures

Primary Outcomes (1)

  • Oxford Knee Score (OKS)

    A 12-item patient-reported questionnaire assessing knee pain and function during daily activities. Each item is scored from 0 to 4, giving a total score ranging from 0 to 48. Higher scores indicate better knee function and less pain.

    The OKS will be completed by participants at baseline before surgery and at 3 and 12 months after surgery. The primary outcome is the change in OKS from baseline to 12 months after surgery.

Secondary Outcomes (8)

  • Objectively measured physical activity (sensor)

    Measurements will be performed during a two-week period before surgery, continuously from surgery to 3 months postoperatively, and during a further two-week period at 12 months after surgery.

  • Objectively measured sleep (sensor)

    Measurements will be performed during a two-week period before surgery, continuously from surgery to 3 months postoperatively, and during a further two-week period at 12 months after surgery.

  • Isometric knee extension and flexion strength

    Measurements will be performed before surgery and at 12 months after surgery.

  • Knee range of motion

    Measurements will be performed before surgery and at 12 months after surgery.

  • Jenkins Sleep Scale (JSS)

    The JSS will be completed at 2 weeks preoperatively and 12 months postoperatively.

  • +3 more secondary outcomes

Study Arms (2)

Medial unicompartmental knee arthroplasty (UKA)

Patients undergoing primary same-day discharge medial unicompartmental knee arthroplasty (UKA) for knee osteoarthritis. The medial UKA group will include 30 participants. The surgical procedure is determined by the treating clinical team according to established clinical indications and is not assigned by the study.

Procedure: Medial unicompartmental knee arthroplasty (UKA)

Total Knee Arthroplasty (TKA)

Patients undergoing primary same-day discharge total knee arthroplasty (TKA) for knee osteoarthritis. The TKA group will include 90 participants. The surgical procedure is determined by the treating clinical team according to established clinical indications and is not assigned by the study.

Procedure: Total knee arthroplasty (TKA)

Interventions

Primary medial UKA performed as part of routine clinical care for knee osteoarthritis. The procedure is not assigned by the study.

Medial unicompartmental knee arthroplasty (UKA)

Primary TKA performed as part of routine clinical care for knee osteoarthritis. The procedure is not assigned by the study.

Total Knee Arthroplasty (TKA)

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients undergoing same-day discharge primary knee arthroplasty: medial UKA or TKA according to standard clinical practice at Turku University Hospital. The choice of procedure is made on clinical grounds by the treating surgeon and is not influenced by study participation. Operations are performed by experienced arthroplasty surgeons under spinal anaesthesia following the hospital's standardized same-day discharge protocol.

You may qualify if:

  • \- Primary knee osteoarthritis: medial or lateral Kellgren Lawrence grade 3-4 for TKA and antero-medial grade 3-4 for UKA.
  • Patient criteria for outpatient knee arthroplasty (UKA or TKA):
  • Full overnight support by an adult at home after discharge
  • At most mild, well-controlled, comorbidities (e.g. hypertension, hypothyroidism, epilepsy, asthma)
  • ASA-class 1-2
  • Age \<80 years
  • BMI \<35 kg/m2

You may not qualify if:

  • Post-traumatic osteoarthritis
  • Neurological disorder aVecting walking or muscle strength
  • Inability or unwillingness to use a smartphone or to participate in the study
  • History of cardiac or cerebrovascular events
  • Conditions affecting consciousness (e.g. syncope of cardiac origin)
  • Untreated or central sleep apnoea
  • Heart failure
  • Diabetes mellitus type 1
  • Cognitive impairment or dementia
  • History of substance abuse
  • Chronic strong opioid therapy or severe pain disorder
  • Antithrombotic therapy (e.g. Xarelto, Pradaxa, Plavix or ASA for secondary prevention)
  • History of venous thromboembolism or known coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The UKK Institute for Health Promotion Research

Tampere, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Ville Äärimaa, Title of Docent

    Turku University Hospital

    STUDY CHAIR
  • Keijo Mäkelä, Professor

    Turku University Hospital

    STUDY CHAIR

Central Study Contacts

Matias Hemmilä, Ph.D.

CONTACT

Juuso Hannula, Ph.D. student

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 25, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

There is currently no plan to make individual participant data (IPD) available to other researchers. The study will collect individual-level clinical, patient-reported, and wearable sensor data, and any sharing of such data would be subject to applicable data protection requirements, ethical considerations, and institutional policies.

Locations