OsteoarthritisNCT02381873
Determinants of Early Functional Outcome After Reconstructive Surgery
An observational study of Osteoarthritis, run by Queen Margaret University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Mar 2016
- 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: Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary total knee arthroplasty (TKA).
Who may be able to join
- Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary TKA.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG
About this study
Official title: Exploratory Study of Determinants of Early Functional Outcome Following Reconstructive Knee Surgery
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.
Read the 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.
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, Replacement, Knee, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Score (KOOS)
Self reported questionnaire which evaluates pain, other symptoms, function in activity of daily living, function in sport and recreation (Sport/Rec), and knee related QoL.
Measured: from 10 weeks prior to surgery to 12 weeks after surgery
Oxford knee score (OKS)
Self reported questionnaire which evaluates pain and function.
Measured: from 10 weeks prior to surgery to 12 weeks after surgery
Postural stability as assesed by force plate
Postural stability will be assessed using a stable force plate.
Measured: from 10 weeks prior to surgery to 12 weeks after surgery
Secondary outcomes (6)
Neuromuscular performance capability
Dynamometer and electromyography measurements will be used to evaluate neuromuscular performance capability.
Measured: from 10 weeks prior to surgery to 12 weeks after surgery
Sensorimotor performance capability
Dynamometer and electromyography measurements will be used to evaluate sensorimotor performance capability.
Measured: from 10 weeks prior to surgery to 12 weeks after surgery
International Physical Activity Questionnaire (IPAQ).
Self-reported physical activity will be monitored using IPAQ.
Measured: from 10 weeks prior to surgery to 12 weeks after surgery
Knee circumference
Measured: from 10 weeks prior to surgery to 12 weeks after surgery
DNA genotypes and subsequent protein expression
Measured: on the day of surgery and 12 weeks following operation
Psychophysiological response
Self reported. Psychophysiological response will be assessed using Category-Ratio Scale (CR-10); performance profile; short form (SF)-36.
Measured: from 10 weeks prior to surgery to 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Peer, Queen Margaret University
- Investigators
- Maria A Peer, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381873
- Sponsor's protocol ID
- 14/NE/1216
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Determinants of Early Functional Outcome Following Reconstructive Knee Surgery
- ClinicalTrials.gov ID
- NCT02381873
- Acronym / sponsor ID
- 14/NE/1216
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, Replacement, Knee, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Mar 2015 (estimated)
- 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary total knee arthroplasty (TKA).
Key inclusion criteria (1 listed)
- Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary TKA.
Key exclusion criteria (4 listed)
- 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
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
Knee Injury and Osteoarthritis Score (KOOS)
Time frame: from 10 weeks prior to surgery to 12 weeks after surgery
Self reported questionnaire which evaluates pain, other symptoms, function in activity of daily living, function in sport and recreation (Sport/Rec), and knee related QoL.
Oxford knee score (OKS)
Time frame: from 10 weeks prior to surgery to 12 weeks after surgery
Self reported questionnaire which evaluates pain and function.
Postural stability as assesed by force plate
Time frame: from 10 weeks prior to surgery to 12 weeks after surgery
Postural stability will be assessed using a stable force plate.
6 secondary outcomes
Neuromuscular performance capability
Time frame: from 10 weeks prior to surgery to 12 weeks after surgery
Sensorimotor performance capability
Time frame: from 10 weeks prior to surgery to 12 weeks after surgery
International Physical Activity Questionnaire (IPAQ).
Time frame: from 10 weeks prior to surgery to 12 weeks after surgery
Knee circumference
Time frame: from 10 weeks prior to surgery to 12 weeks after surgery
DNA genotypes and subsequent protein expression
Time frame: on the day of surgery and 12 weeks following operation
Psychophysiological response
Time frame: from 10 weeks prior to surgery to 12 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
Related trials for Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Active, not recruiting
Balneotherapy in Hand Osteoarthritis
Hand Osteoarthritis
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
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.
Maria A Peer principal investigator
Queen Margaret 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 Osteoarthritis, run by Queen Margaret University 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 7 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Score (KOOS) (time frame: from 10 weeks prior to surgery to 12 weeks after surgery). The study lists 3 primary outcomes in all. 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 7 Mar 2017.