Clinical trial NCT03518866: Patient Recovery After Knee Replacement Surgery
Official title: A Feasibility Study to Monitor Post Discharge Activity of Patient Recovery After Knee Replacement Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Knee Replacement
Lead sponsor: Milton Keynes University Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Open University
First posted: 2018-05-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

\* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in mean weekly step count between pre surgery and 6 weeks post surgery.
timeFrame: 7 weeks
measure: Mean Daily Pain Score over 6 weeks following surgery
timeFrame: 6 weeks
measure: Mean weekly Oxford Knee Score for 6 weeks following surgery.
timeFrame: 6 weeks
measure: The OKS (Oxford Knee Score) at 6 months post surgery
timeFrame: 6 months
measure: The OKS (Oxford Knee Score) at 12 months post surgery
timeFrame: 12 months
measure: The Pain score at 6 months post surgery
timeFrame: 6 months
measure: The Pain score at 12 months post surgery
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital NHS Foundation Trust
state: Bucks
Study officials:
affiliation: Open University
name: Blaine Price
role: STUDY_CHAIR
References:
citation: 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.