Total Knee ReplacementNCT03518866
Patient Recovery After Knee Replacement Surgery
An observational study of Total Knee Replacement, run by Bev Hoddell at 1 site in United Kingdom.
Trial summary
This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jul 2015to 31 Dec 2018
- 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: Adults undergoing elective single total knee replacement surgery at Milton Keynes University Hospital under the care of the principal investigator with no other relevant co-morbidities.
Who may be able to join
- Adult
- Must be able to converse and understand English
- The participants must be selected for for single full knee replacement surgery at Milton Keynes University Hospital
- The participant must have access to a computer at home or be willing to plug a synchronization box into their broadband router
- The participants must have access to a valid email address or be able to create one for the purpose of this study (this may belong to a spouse, partner, friend or relative) or have access to a mobile phone able to receive SMS (text) messages
Who cannot join
- Insufficient language skills to understand the study procedures
- Cognitive impairment
- Medical conditions (e.g., severe neurological disorder, acute cancer, psychiatric disorder, acute infections) that prevent participation in the study
- Wheelchair user
- Significant lower limb arthritic joints
- Severe mobility limitation due to central or peripheral respiratory dysfunction
Show all 12Show fewer
- Severe mobility limitation due to central or peripheral nervous system disorders
- Severe mobility limitation due to spinal condition
- Severe mobility limitation due to musculoskeletal disabilities
- Rheumatoid arthritis due to joint pain in both upper and lower limbs
- Amputee
- Dementia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes, Bucks, MK6 5LD
About this study
Official title: A Feasibility Study to Monitor Post Discharge Activity of Patient Recovery After Knee Replacement Surgery
This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.
Read the detailed description
This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.
Primary Aims The primary objective of this study is to compare step count and activity levels with key outcome measures - including pain scores and painkiller usage - to determine whether more active people have better recovery.
- Conditions
- Total Knee Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean weekly step count between pre surgery and 6 weeks post surgery.
Daily activity level of participant as measured by step count automatically on commercial step counter at one minute granularity from up to one week before surgery up to 6 weeks post surgery. Step count data for days which are deemed non compliant (not wearing device long enough) will be ignored. Total average daily step count (for compliant days) each week will be reported.
The outcome measure we plan to use will be the mean daily step count from the 6th week post op. The baseline will be the mean step count from the 1 week prior to surgery.
Measured: 7 weeks
Mean Daily Pain Score over 6 weeks following surgery
Participants will be asked to record their NRS-11 (Numeric Rating Scale) pain level in the morning, afternoon and evening daily in a paper diary for six weeks after surgery. NRS-11 is an integer scale from 0-10 with 0 representing no pain and 10 representing worst pain possible.
The outcome measure will be the mean pain score from the 6 week post op period.
Measured: 6 weeks
Mean weekly Oxford Knee Score for 6 weeks following surgery.
For the 6 weeks following surgery, at the end of each week patients will be asked to fill in the 12 question Oxford Knee Score (OKS) questionnaire which will result in an integer score from 0-48 for each week.
The outcome measure will be the mean OKS over the 6 week post op period.
Measured: 6 weeks
The OKS (Oxford Knee Score) at 6 months post surgery
Routine physiotherapy review appointment 6 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.
Measured: 6 months
The OKS (Oxford Knee Score) at 12 months post surgery
Routine physiotherapy review appointment 12 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.
Measured: 12 months
The Pain score at 6 months post surgery
Routine physiotherapy review appointment 6 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.
Measured: 6 months
The Pain score at 12 months post surgery
Routine physiotherapy review appointment 12 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start21 Jul 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bev Hoddell
- Sponsor type
- Other government
- Collaborators
- Open University
- Responsible party
- Sponsor-investigator, Bev Hoddell, Milton Keynes University Hospital NHS Foundation Trust
- Investigators
- Blaine Price, Study chair, Open University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518866
- Sponsor's protocol ID
- 14-MK-002
- Status last verified
- Apr 2018
- First submitted
- 11 Sep 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised raw participant data for basic demographics, surgery date, daily step count, pain scores, Oxford Knee scores will be shared on the institutional open data archive.
Publications
Kelly R, Jones S, Price B, Katz D, McCormick C, Pearce O. Measuring Daily Compliance With Physical Activity Tracking in Ambulatory Surgery Patients: Comparative Analysis of Five Compliance Criteria. JMIR Mhealth Uhealth. 2021 Jan 26;9(1):e22846. doi: 10.2196/22846.
PubMed 33496677
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Monitor Post Discharge Activity of Patient Recovery After Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT03518866
- Acronym / sponsor ID
- 14-MK-002
- Conditions
- Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bev HoddellOther government
- Collaborators
- Open University
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 8 May 2018 (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.
This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.
Detailed description
This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.
Primary Aims The primary objective of this study is to compare step count and activity levels with key outcome measures - including pain scores and painkiller usage - to determine whether more active people have better recovery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing elective single total knee replacement surgery at Milton Keynes University Hospital under the care of the principal investigator with no other relevant co-morbidities.
Key inclusion criteria (5 listed)
- Adult
- Must be able to converse and understand English
- The participants must be selected for for single full knee replacement surgery at Milton Keynes University Hospital
- The participant must have access to a computer at home or be willing to plug a synchronization box into their broadband router
- The participants must have access to a valid email address or be able to create one for the purpose of this study (this may belong to a spouse, partner, friend or relative) or have access to a mobile phone able to receive SMS (text) messages
Key exclusion criteria (12 listed)
- Insufficient language skills to understand the study procedures
- Cognitive impairment
- Medical conditions (e.g., severe neurological disorder, acute cancer, psychiatric disorder, acute infections) that prevent participation in the study
- Wheelchair user
- Significant lower limb arthritic joints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in mean weekly step count between pre surgery and 6 weeks post surgery.
Time frame: 7 weeks
Daily activity level of participant as measured by step count automatically on commercial step counter at one minute granularity from up to one week before surgery up to 6 weeks post surgery. Step count data for days which are deemed non compliant (not wearing device long enough) will be ignored. Total average daily step count (for compliant days) each week will be reported. The outcome measure we plan to use will be the mean daily step count from the 6th week post op. The baseline will be the mean step count from the 1 week prior to surgery.
Mean Daily Pain Score over 6 weeks following surgery
Time frame: 6 weeks
Participants will be asked to record their NRS-11 (Numeric Rating Scale) pain level in the morning, afternoon and evening daily in a paper diary for six weeks after surgery. NRS-11 is an integer scale from 0-10 with 0 representing no pain and 10 representing worst pain possible. The outcome measure will be the mean pain score from the 6 week post op period.
Mean weekly Oxford Knee Score for 6 weeks following surgery.
Time frame: 6 weeks
For the 6 weeks following surgery, at the end of each week patients will be asked to fill in the 12 question Oxford Knee Score (OKS) questionnaire which will result in an integer score from 0-48 for each week. The outcome measure will be the mean OKS over the 6 week post op period.
The OKS (Oxford Knee Score) at 6 months post surgery
Time frame: 6 months
Routine physiotherapy review appointment 6 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.
The OKS (Oxford Knee Score) at 12 months post surgery
Time frame: 12 months
Routine physiotherapy review appointment 12 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.
The Pain score at 6 months post surgery
Time frame: 6 months
Routine physiotherapy review appointment 6 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.
The Pain score at 12 months post surgery
Time frame: 12 months
Routine physiotherapy review appointment 12 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 33496677Kelly R, Jones S, Price B, Katz D, McCormick C, Pearce O. Measuring Daily Compliance With Physical Activity Tracking in Ambulatory Surgery Patients: Comparative Analysis of Five Compliance Criteria. JMIR Mhealth Uhealth. 2021 Jan 26;9(1):e22846. doi: 10.2196/22846.
- Individual participant dataSharing planned: Yes. Anonymised raw participant data for basic demographics, surgery date, daily step count, pain scores, Oxford Knee scores will be shared on the institutional open data archive.
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Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
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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.
Blaine Price study chair
Open University
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 Total Knee Replacement, run by Bev Hoddell 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 5 inclusion and 12 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 8 May 2018. 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?
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?
Change in mean weekly step count between pre surgery and 6 weeks post surgery. (time frame: 7 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03518866, which also lists 1 linked publication.
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 8 May 2018.