Arthroplasty, Replacement, KneeNCT04240769
Physical Activity Levels During Recovery Following Knee Arthroplasty
An observational study of Arthroplasty, Replacement, Knee, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The goal of this study is to utilize physical activity monitoring to determine the trajectory of normal recovery as it relates to a patient's ability to get up and get moving. From this work, we hope to be able to define the range in patients' physical activity following knee replacement surgery, and thus, give… 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?
- Total or Partial Knee Arthroplasty
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2020to 1 Oct 2021
- 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: Participants will be patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with required late stage osteoarthritis, undergoing knee arthroplasty in the next 3 months.
- In Investigator's opinion, is able and willing to comply with all trial requirements.
Who cannot join
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who are enrolled in another research study involving an investigational product or methodology that could alter physical activity.
- Participants are undergoing a revision arthroplasty surgery on the operative knee
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
Oxford, Oxfordshire, OX3 7LD
Gail Lang, gail.lang@ndorms.ox.ac.uk
Andrew J Price, DPhil, FRCS
About this study
Official title: Identifying the Trajectory of Normal Recovery Following Knee Arthroplasty Through Physical Activity Monitoring Via Wrist-Worn Accelerometry
The goal of this study is to utilize physical activity monitoring to determine the trajectory of normal recovery as it relates to a patient's ability to get up and get moving. From this work, we hope to be able to define the range in patients' physical activity following knee replacement surgery, and thus, give clinicians a tool and the methodology to identify patients whose recovery is not progressing as quickly as expected. Data from physical activity monitors will allow the research team to identify how active patients are, how vigorous that activity is, and how well that activity correlates with standard and commonly used patient questionnaires.
Read the detailed description
This study is an observational study of the physical activity levels of adults who have been diagnosed with end-stage osteoarthritis of the knee and are undergoing knee replacement surgery at the Nuffield Orthopaedic Centre, Oxford. Data regarding patient activity and functional recovery will be collected using two methods. First, data will be collected through the extraction of three-axis accelerometer data, collected via a wrist-worn (and hip-worn for a subset of patients) physical activity monitor. This data will be collected in three intervals: pre-operatively, immediately postoperatively, and at 6 months postoperatively. Secondly, data will be collected by standard clinical assessment and patient reported outcome measures. These assessments will again take place pre-operatively, at 6 weeks postoperatively, and at 6 months postoperatively. Additional data will be collected through a simple activity diary, which asks the participants to log their monitor wear-time along with the times that they took bicycle rides or extended walks.
The expected duration of patient involvement is up to a total of 8 to 8.5 weeks over the course of up to 7 months. There are no clinical visits within this protocol beyond what is already within normal patient care. Patients will be asked to post their monitor back to the research centre for data collection and data processing twice during the study period.
The aim of this study is to assess the trajectory of recovery in terms of physical activity in the post-operative knee replacement population, and subsequently to define the expected path of early recovery.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Total or Partial Knee Arthroplasty
- Keywords
- physical activity, rehabilitation, accelerometry
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total or Partial Knee ArthroplastyDevice
Also called Knee Replacement
Reconstruction of part or all of the native articulation at the knee joint via implant.
| Study group | Role | What they receive |
|---|---|---|
| Knee Arthroplasty Patient | Patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis. Receives: Device: Total or Partial Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
The primary outcome measure will physical activity, as extracted from analysis of raw accelerometer data from the activity monitor. Several variables will be extracted from the raw data, including average acceleration vector (Euclidean norm minus one), bouts of physical activity and percentage of active and sedentary time.
Measured: Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively.
Secondary outcomes (4)
Change in Oxford Knee Score
A patient reported outcome measure to assess patient benefit [Range 0 to 48, higher scores corresponding to better outcomes].
Measured: Pre-operative (baseline), 6 weeks, 6 months
Change in EQ-5D-5L
A patient reported outcome measure to assess patient benefit. As summary index score from 0 to 1 is given, where 0 is the health state equivalent to dead, 1 is a full healthy outcome, and negative indicates a health state worse than dead. The score is derived from five sections (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression) scored 1 to 5, with higher corresponding to better outcomes. A second visual analogue score for perceived health is reported from 0 to 100 with higher scores indicating better perceived overall health.
Measured: Pre-operative (baseline), 6 weeks, 6 months
Change in University of California, Los Angeles (UCLA) Activity Score
A self-reported score to assess patient benefit and physical activity. The score ranges from 1 to 10 where higher scores indicate greater levels of physical activity
Measured: Pre-operative (baseline), 6 weeks, 6 months
Change in International Physical Activity Questionnaire Questionnaire - Short Form
A self-reported score to assess patient benefit and physical activity. The score can be reported in one of three categories: Low, Moderate, or High physical activity.
Measured: Pre-operative (baseline), 6 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start31 Jan 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
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 University of OxfordThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott R Small, MS, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240769
- Sponsor's protocol ID
- IRAS 260855
- Other IDs
- 19/SW/0151
- Status last verified
- Jul 2020
- First submitted
- 22 Jan 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Trajectory of Normal Recovery Following Knee Arthroplasty Through Physical Activity Monitoring Via Wrist-Worn Accelerometry
- ClinicalTrials.gov ID
- NCT04240769
- Acronym / sponsor ID
- IRAS 260855
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- physical activity, rehabilitation, accelerometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 27 Jan 2020 (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.
The goal of this study is to utilize physical activity monitoring to determine the trajectory of normal recovery as it relates to a patient's ability to get up and get moving. From this work, we hope to be able to define the range in patients' physical activity following knee replacement surgery, and thus, give clinicians a tool and the methodology to identify patients whose recovery is not progressing as quickly as expected. Data from physical activity monitors will allow the research team to identify how active patients are, how vigorous that activity is, and how well that activity correlates with standard and commonly used patient questionnaires.
Detailed description
This study is an observational study of the physical activity levels of adults who have been diagnosed with end-stage osteoarthritis of the knee and are undergoing knee replacement surgery at the Nuffield Orthopaedic Centre, Oxford. Data regarding patient activity and functional recovery will be collected using two methods. First, data will be collected through the extraction of three-axis accelerometer data, collected via a wrist-worn (and hip-worn for a subset of patients) physical activity monitor. This data will be collected in three intervals: pre-operatively, immediately postoperatively, and at 6 months postoperatively. Secondly, data will be collected by standard clinical assessment and patient reported outcome measures. These assessments will again take place pre-operatively, at 6 weeks postoperatively, and at 6 months postoperatively. Additional data will be collected through a simple activity diary, which asks the participants to log their monitor wear-time along with the times that they took bicycle rides or extended walks.
The expected duration of patient involvement is up to a total of 8 to 8.5 weeks over the course of up to 7 months. There are no clinical visits within this protocol beyond what is already within normal patient care. Patients will be asked to post their monitor back to the research centre for data collection and data processing twice during the study period.
The aim of this study is to assess the trajectory of recovery in terms of physical activity in the post-operative knee replacement population, and subsequently to define the expected path of early recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Arthroplasty Patient | – | Device: Total or Partial Knee ArthroplastyPatients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with required late stage osteoarthritis, undergoing knee arthroplasty in the next 3 months.
- In Investigator's opinion, is able and willing to comply with all trial requirements.
Key exclusion criteria (3 listed)
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who are enrolled in another research study involving an investigational product or methodology that could alter physical activity.
- Participants are undergoing a revision arthroplasty surgery on the operative knee
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 |
|---|---|---|
| Total or Partial Knee ArthroplastyAlso: Knee ReplacementReconstruction of part or all of the native articulation at the knee joint via implant. | Device | Knee Arthroplasty Patient |
Primary outcome
Change in physical activity
Time frame: Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively.
The primary outcome measure will physical activity, as extracted from analysis of raw accelerometer data from the activity monitor. Several variables will be extracted from the raw data, including average acceleration vector (Euclidean norm minus one), bouts of physical activity and percentage of active and sedentary time.
4 secondary outcomes
Change in Oxford Knee Score
Time frame: Pre-operative (baseline), 6 weeks, 6 months
Change in EQ-5D-5L
Time frame: Pre-operative (baseline), 6 weeks, 6 months
Change in University of California, Los Angeles (UCLA) Activity Score
Time frame: Pre-operative (baseline), 6 weeks, 6 months
Change in International Physical Activity Questionnaire Questionnaire - Short Form
Time frame: Pre-operative (baseline), 6 weeks, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Scott R Small, MS principal investigator
University of Oxford
1 site 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 University of Oxford at 1 site in United Kingdom.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew J Price, DPhil, FRCS (+44 01865 223421, andrew.price@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity (time frame: Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively.). 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 27 Jul 2020.