Protocol for a Multicenter Study on (Cost)Effectiveness of the Back At Work After Surgery (BAAS): a Clinical Pathway for Knee Arthroplasty

NCT05690347 | Unknown

• 1 other identifier: 10320052010006
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background Optimizing return to work (RTW) after knee arthroplasty (KA) is becoming increasingly important due to a growing incidence of KA and poor RTW outcomes after KA. We developed the Back At work After Surgery (BAAS) clinical pathway for optimized RTW after KA. Since the effectiveness and cost analysis of the BAAS clinical pathway are still unknown, analysis on effectiveness and costs of BAAS is imperative. Method This protocol paper has been written in line with the standards of Standard Protocol Items: Recommendations for Interventional Trails. To assess the effectiveness and cost-effectiveness for RTW, we will perform a multicenter prospective cohort study with patients who decided to receive a total KA (TKA) or an unicompartmental KA (UKA). To evaluate the effectiveness of BAAS regarding RTW, a comparison to usual care will be made using individual patient data on RTW from prospectively performed cohort studies in the Netherlands. Discussion One of the strengths of this study is that the feasibility for the BAAS clinical pathway was tested at first hand. Also, we will use validated questionnaires and functional tests to assess the patient's recovery using robust outcomes. Moreover, the intervention was performed in two hospitals serving the targeted patient group and to reduce selection bias and improve generalizability. The limitations of this study protocol are that the lead author has an active role as a medical case manager (MCM) in one of the hospitals. Additionally, we will use the data from other prospective Dutch cohort studies to compare our findings regarding RTW to usual care. Since we will not perform an RCT, we will use propensity analysis to reduce the bias due to possible differences between these cohorts.

Conditions

Arthropathy of Knee

Outcome Measures

Primary Outcomes (2)

• Return to work

  1 year

• costs

  1 year

Interventions

Back At work After Surgery (BAAS) BEHAVIORAL

see protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

see protocol

nclusion criteria for patients are: (ii) being scheduled for primary or revision UKA or TKA by an orthopedic surgeon between January 2022 and July 2023; (ii) having paid work for at least eight hours a week before surgery; (iii) being between 18 and 65 years of age and (iv) having the intention to fully RTW after surgery. Criteria to exclude patients are: (i) receiving more than one medical event within one year that affects work ability after KA; (ii) having a KA for any other reason than knee osteoarthritis; and (iii) having major disabling mental disorders. Patients who do not speak or read Dutch are given the opportunity to fill in the questionnaires with the aid of a translator and to have an interpreter present during the consultations. Patients who are eligible to participate are informed about the study by telephone by the medical case manager (MCM; physical therapist working in the hospital). During an intake consultation with an MCM, the patient information letter, informed consent, and an infographic of the BAAS clinical pathway (Appendix I) are handed out to the patient. Patients' questions regarding participation are answered. Patients are given one week to decide whether or not they wish to participate. Patients who opted for the possibility to participate receive a telephone call after one week so that they can ask any additional questions about the study and they will be asked if they want to participate. Participants willing to participate sign the informed consent.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Nij Smellinghe

Drachten, Provincie Friesland, 9202 NN, Netherlands

RECRUITING

Related Publications (3)

• Strijbos DO, Straat AC, van der Sluis G, van Houtert WFC, van Dongen JM, Boymans T, Kuijer PPFM, Reneman MF. Return on Investment of the Back At Work After Surgery (BAAS) Care Pathway Compared to Care-as-Usual in Knee Arthroplasty. J Occup Rehabil. 2025 Dec;35(4):958-966. doi: 10.1007/s10926-025-10328-w. Epub 2025 Sep 19.

  PMID: 40971108 DERIVED

• Strijbos DO, van der Sluis G, van Houtert WFC, Straat AC, van Zaanen Y, Kooijman CM, van den Brand I, de Groot SE, Reneman MF, Boymans T, Kuijer PPFM. The Effectiveness of the Back At work After Surgery (BAAS) Work-Integrated Care Pathway on Return to Work for Patients Receiving Knee Arthroplasty: A Study of Three Comparative Cohorts in the Netherlands. J Occup Rehabil. 2025 Dec;35(4):967-977. doi: 10.1007/s10926-025-10331-1. Epub 2025 Sep 16.

  PMID: 40956371 DERIVED

• Strijbos DO, van der Sluis G, van Houtert WFC, Straat AC, van Zaanen Y, de Groot S, Klomp S, Krijnen WP, Kooijman CM, van den Brand I, Reneman MF, Boymans TAEJ, Kuijer PPFM. Protocol for a multicenter study on effectiveness and economics of the Back At work After Surgery (BAAS): a clinical pathway for knee arthroplasty. BMC Musculoskelet Disord. 2023 Mar 16;24(1):199. doi: 10.1186/s12891-023-06203-5.

  PMID: 36927339 DERIVED

Study Officials

• Paul Kuijer, Dr

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

daniel strijbos, PhD student

CONTACT

+31622202362; d.o.strijbos@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHYSICAL THERAPIST AND RESEARCHER

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: January 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

NL (1)