Clinical trial NCT02381873: Determinants of Early Functional Outcome After Reconstructive Surgery
Official title: Exploratory Study of Determinants of Early Functional Outcome Following Reconstructive Knee Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Arthroplasty
Replacement
Knee
Osteoarthritis
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary total knee arthroplasty (TKA).

Brief summary: This exploratory study will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological and genotypical performance capabilities and levels of habitual physical activity prior to and around the time of surgery.

Detailed description: Despite the positive outcomes of total knee arthroplasty (TKA) surgery on symptoms such as pain, perceived function and health-related quality of life (QoL) current research highlights the persistent deleterious effects of retained aberrant neuromuscular alterations on physical function, which may also directly impact falls risk. Importantly, observed increases in neuromuscular deficits that occur prior to surgery track through into the post-operative stage with functional limitations that are sustained and which can persist at least one year after surgery. Clearly, it is crucial to strive to identify modifiable factors that might successfully ameliorate this pathophysiological process prior to surgery, reduce post surgical impairments and which also accelerate recovery.

Among other determinants that might contribute towards understanding of optimal functional recovery following reconstructive knee surgery is the influence of genes. The evaluation of specific genotypes and subsequent protein expression might provide further insight into the extent of genetic influence. For example, it is not yet known whether patients with specific genotypes experience an accelerated recovery. Currently, there is a paucity of research on the influence of gene-environment interactions on an individual's response to physical conditioning.

The proposed research will be an exploratory study, involving four repeated-measures assessments from 10 weeks prior to surgery to 12 weeks after surgery. This study offers a novel evaluation of the overall patterning of changes and will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological performance capabilities, genotypes and levels of habitual physical activity.

Eligibility criteria: Inclusion Criteria:

* Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary TKA.

Exclusion Criteria:

* Individuals electing primary knee arthroplasty surgery due to a knee joint disease other than osteoarthritis
* Rheumatic disorder
* Other orthopaedic conditions affecting lower body function
* Neurological disorders

Primary outcomes:
measure: Knee Injury and Osteoarthritis Score (KOOS)
timeFrame: from 10 weeks prior to surgery to 12 weeks after surgery
measure: Oxford knee score (OKS)
timeFrame: from 10 weeks prior to surgery to 12 weeks after surgery
measure: Postural stability as assesed by force plate
timeFrame: from 10 weeks prior to surgery to 12 weeks after surgery
Secondary outcomes:
measure: Neuromuscular performance capability
timeFrame: from 10 weeks prior to surgery to 12 weeks after surgery
measure: Sensorimotor performance capability
timeFrame: from 10 weeks prior to surgery to 12 weeks after surgery
measure: International Physical Activity Questionnaire (IPAQ).
timeFrame: from 10 weeks prior to surgery to 12 weeks after surgery
measure: Knee circumference
timeFrame: from 10 weeks prior to surgery to 12 weeks after surgery
measure: DNA genotypes and subsequent protein expression
timeFrame: on the day of surgery and 12 weeks following operation
measure: Psychophysiological response
timeFrame: from 10 weeks prior to surgery to 12 weeks after surgery
Other outcomes:
Locations:
city: Oswestry
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
state: Shropshire
Study officials:
affiliation: Queen Margaret University
name: Maria A Peer
role: PRINCIPAL_INVESTIGATOR
References: