Preoperative Prediction of Postoperative Physical Function

NCT05602701 | Terminated

• 1 other identifier: NL.78977.068.21
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

End-stage KOA results in limitations in activities of daily life (ADL), work and leisure. Treatment for KOA is a stepped care process starting with a conservative approach and in which joint replacement surgery can be considered as the last step. Total knee arthroplasty (TKA) is regarded as the gold standard for the treatment of end-stage knee osteoarthritis (KOA). In 2020, 19.501 TKA surgeries were performed in The Netherlands, end-stage KOA being (97%) the most common reason for surgery. Until now no risk inventory prediction models have been made for the prediction of physical function at six weeks after TKA. These models may help to distinguish between having a high risk or low risk on a delayed recovery of physical function at six weeks after TKA. This could be beneficial for patients with a high risk. Because than the perioperative process of this patientgroup can be optimized and improved.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Preoperative; Total Knee Arthroplasty; Prediction; Physical therapy; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score

  The Knee injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of the knee injury. The measurement consists out of 42 items, divided in 5 domains (Pain, Symptoms, ADL, leisure and sports and QoL). The total score varies between 0-100. A higher score indicates less knee and knee associated problems.

  The KOOS is measured at 6 weeks postoperative

Study Arms (1)

Patients awaiting TKA

Patients awaiting unilateral total knee arthroplasty due to end-stage knee osteoarthritis.

Other: Preoperative assessment

Interventions

Preoperative assessment OTHER

Preoperative assessment of physical fitness

Patients awaiting TKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who are awaiting unilateral TKA and will be recruited from the orthopeadic departments from the Annadal Clinic, Zuyderland Medical Centre and Maasticht University Medical Center+.

You may qualify if:

• Scheduled for primary unilateral TKA surgery
• TKA surgery due to end-stage OA of the knee
• Able to perform the preoperative assessment 4 weeks before surgery
• Able to fulfill the KOOS by phone 6 weeks postoperatively
• Mastery of the Dutch language

You may not qualify if:

• Undergoing revision arthroplasty, bilateral TKA or hemi-arthroplasty surgery
• TKA not due to KOA
• Patients who weren't able to perform the preoperative assessment or to fulfill the KOOS postoperatively
• Cognitive impairments
• Complete dependence on a wheelchair
• Unable to sign the informed consent form

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Annadal Clinic: collaborator
• Zuyderland Medical Centre: collaborator

Study Sites (3)

Annadal Clinic

Maastricht, Limburg, 6216EG, Netherlands

Location

Maastricht University Medical Center+

Maastricht, Limburg, 6229HX, Netherlands

Location

Zuyderland Medical Centre

Sittard, Limburg, 6162BG, Netherlands

Location

Study Officials

• Antoine F Lenssen, Prof. PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: October 25, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)