Arthroplasty, Replacement, KneeNCT05602701
Preoperative Prediction of Postoperative Physical Function
An observational study of Arthroplasty, Replacement, Knee, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Preoperative assessment
- How many people
- 40 participants
- Where
- 3 sitesNetherlands
- Study dates
- 25 Oct 2022to 1 Dec 2023
- 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: 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+.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Annadal Clinic
Maastricht, Limburg, 6216EG
Maastricht University Medical Center+
Maastricht, Limburg, 6229HX
Zuyderland Medical Centre
Sittard, Limburg, 6162BG
About this study
Official title: Preoperative Prediction of Postoperative Physical Function in Patients With Total Knee Arthroplasty Based on Physical Fitness and Patient Characteristics: A Prospective Cohort Study
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.
Read the detailed description
Rationale: One of the most common degenerative joint disorders is osteoarthritis (OA). It is most frequently localized in the knee joint. In 2019, the prevalence of knee osteoarthritis (KOA) in the Netherlands reached 704.600 patients. Due to the increase in patients with KOA, healthcare costs are rising. Delayed recovery also causes rising healthcare costs. Preoperative physical fitness turned out to be a predictor of postoperative recovery. A recently published systematic review shows effects of preoperative physical therapy up to 3 months after surgery. To provide therapy to only those who need it, physiotherapeutic care can be optimized and healthcare costs can be saved. Therefore a prediction model, based on physical fitness and patient characteristics, is made to predict the recovery of physical function 6 weeks after total knee arthroplasty.
Objective: To investigate if a risk model can be made, based on physical fitness and patient characteristics, to predict recovery of physical function 6 weeks after total knee arthroplasty. Secondary Objective: To explore if this model is able to distinguish between low risk and high risk of a delayed recovery of physical function.
Study design: Prospective cohort study.
Study population: The study population consists out of patients from the orthopaedic department at the Maastricht University Medical Center + (MUMC+), Zuyderland Medical Centre and the Annadal Clinic, with a diagnosis of end-stage KOA. All patients are scheduled for unilateral primary TKA surgery, because of failing of conservative treatments.
Main study parameters/endpoints: The primary outcome is postoperative physical function (KOOS) 6 weeks after TKA surgery. Predicted by physical fitness and patient characteristics measured during the preoperative assessment. The KOOS is a measurement tool to assess the patients opinion about their knee and associated problems.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During this examination, the burden on the patient is minimal. The patient will visit the physical therapist once for the preoperative assessment. This appointment will follow already scheduled appointments with the specialist and will last up to 45 minutes. In addition, the subject will receive a one-time phone call. This phone call will be a maximum of 10 minutes, for completing the KOOS questionnaire. The preoperative assessment does not involve any risks.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Preoperative assessment
- Keywords
- Preoperative, Total Knee Arthroplasty, Prediction, Physical therapy, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative assessmentOther
Preoperative assessment of physical fitness
| Study group | Role | What they receive |
|---|---|---|
| Patients awaiting TKA | Patients awaiting unilateral total knee arthroplasty due to end-stage knee osteoarthritis. Receives: Other: Preoperative assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The KOOS is measured at 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start25 Oct 2022
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
Why it stopped: Intended inclusion rate was not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Annadal Clinic, Zuyderland Medical Centre
- Responsible party
- Sponsor
- Investigators
- Antoine F Lenssen, Prof. PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602701
- Sponsor's protocol ID
- NL.78977.068.21
- Status last verified
- Feb 2024
- First submitted
- 27 Oct 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not intent to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Prediction of Postoperative Physical Function in Patients With Total Knee Arthroplasty Based on Physical Fitness and Patient Characteristics: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05602701
- Acronym / sponsor ID
- NL.78977.068.21
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Preoperative, Total Knee Arthroplasty, Prediction, Physical therapy, Physiotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Intended inclusion rate was not met
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Annadal Clinic, Zuyderland Medical Centre
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 2 Nov 2022 (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.
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.
Detailed description
Rationale: One of the most common degenerative joint disorders is osteoarthritis (OA). It is most frequently localized in the knee joint. In 2019, the prevalence of knee osteoarthritis (KOA) in the Netherlands reached 704.600 patients. Due to the increase in patients with KOA, healthcare costs are rising. Delayed recovery also causes rising healthcare costs. Preoperative physical fitness turned out to be a predictor of postoperative recovery. A recently published systematic review shows effects of preoperative physical therapy up to 3 months after surgery. To provide therapy to only those who need it, physiotherapeutic care can be optimized and healthcare costs can be saved. Therefore a prediction model, based on physical fitness and patient characteristics, is made to predict the recovery of physical function 6 weeks after total knee arthroplasty.
Objective: To investigate if a risk model can be made, based on physical fitness and patient characteristics, to predict recovery of physical function 6 weeks after total knee arthroplasty. Secondary Objective: To explore if this model is able to distinguish between low risk and high risk of a delayed recovery of physical function.
Study design: Prospective cohort study.
Study population: The study population consists out of patients from the orthopaedic department at the Maastricht University Medical Center + (MUMC+), Zuyderland Medical Centre and the Annadal Clinic, with a diagnosis of end-stage KOA. All patients are scheduled for unilateral primary TKA surgery, because of failing of conservative treatments.
Main study parameters/endpoints: The primary outcome is postoperative physical function (KOOS) 6 weeks after TKA surgery. Predicted by physical fitness and patient characteristics measured during the preoperative assessment. The KOOS is a measurement tool to assess the patients opinion about their knee and associated problems.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During this examination, the burden on the patient is minimal. The patient will visit the physical therapist once for the preoperative assessment. This appointment will follow already scheduled appointments with the specialist and will last up to 45 minutes. In addition, the subject will receive a one-time phone call. This phone call will be a maximum of 10 minutes, for completing the KOOS questionnaire. The preoperative assessment does not involve any risks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients awaiting TKA | – | Other: Preoperative assessmentPatients awaiting unilateral total knee arthroplasty due to end-stage knee osteoarthritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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+.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative assessmentPreoperative assessment of physical fitness | Other | Patients awaiting TKA |
Primary outcome
Knee injury and Osteoarthritis Outcome Score
Time frame: The KOOS is measured at 6 weeks postoperative
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.
Results and safety
The study was stopped early (reason given: Intended inclusion rate was not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No. We do not intent to make IPD available to other researchers.
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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.
Antoine F Lenssen, Prof. PhD principal investigator
Maastricht University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Knee, run by Maastricht University Medical Center at 3 sites in Netherlands.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
The study was stopped early (reason given: Intended inclusion rate was not met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (time frame: The KOOS is measured at 6 weeks postoperative). 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 1 Mar 2024.