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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01899443




Registration number
NCT01899443
Ethics application status
Date submitted
10/07/2013
Date registered
15/07/2013
Date last updated
24/03/2017

Titles & IDs
Public title
Improving Services and Outcomes for Joint Replacement Patients
Scientific title
Improving Services and Outcomes for Joint Replacement Patients
Secondary ID [1] 0 0
ISOAJRS_AU
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Observation

Total hip and knee replacement patients - This study will select up to 20 high volume (\>275 cases annually) public and private hospitals across Australia. A random sample of c.2200 patients with diagnosis of osteoarthritis undergoing primary total hip or knee replacement surgery will be recruited.


Other interventions: Observation
This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants experiencing the composite outcome up to 35 days post surgery.
Timepoint [1] 0 0
35 days post total hip or knee replacement surgery
Secondary outcome [1] 0 0
Patient-reported quality of life
Timepoint [1] 0 0
35 days post surgery
Secondary outcome [2] 0 0
Incidence of venous thromboembolism
Timepoint [2] 0 0
90 days post surgery
Secondary outcome [3] 0 0
Incidence of deep infection.
Timepoint [3] 0 0
365 days post surgery
Secondary outcome [4] 0 0
Costs of care processes
Timepoint [4] 0 0
90 days post surgery
Secondary outcome [5] 0 0
Patient reported quality of life (QoL)
Timepoint [5] 0 0
90 days post surgery
Secondary outcome [6] 0 0
Health-related QoL
Timepoint [6] 0 0
365 days post surgery
Secondary outcome [7] 0 0
Patient reported joint pain and function
Timepoint [7] 0 0
90 days post surgery
Secondary outcome [8] 0 0
Patient reported joint pain and function
Timepoint [8] 0 0
365 days post surgery

Eligibility
Key inclusion criteria
* Primary elective unilateral or bilateral total knee arthroplasty (TKA) or total hip arthroplasty (THA)
* Primary diagnosis of osteoarthritis
* Aged 18 or over, either gender
* Able to comprehend the protocol and provide consent (e.g. be able to read English, have no history of dementia)
* Available for telephone follow-up within the first 6 weeks, 3 months and then at 12 months post surgery
* No further joint replacement surgery planned within the next 3 months of the current surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cognitive impairment / history of dementia
* Hip replacement for fracture
* Revision of previous joint replacement
* Under 18 years of age

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
1900
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Concealed site 4 Public - Rural
Recruitment hospital [2] 0 0
Concealed site 6 Private - Rural
Recruitment hospital [3] 0 0
Concealed site 8 Private - Rural
Recruitment hospital [4] 0 0
Concealed site 16 Public - Semi Rural
Recruitment hospital [5] 0 0
Concealed site 1 Public - Sydney
Recruitment hospital [6] 0 0
Concealed site 17 Private - Sydney
Recruitment hospital [7] 0 0
Concealed site 2 Public - Sydney
Recruitment hospital [8] 0 0
Concealed Site 3 Public - Sydney
Recruitment hospital [9] 0 0
Concealed site 5 Private - Sydney
Recruitment hospital [10] 0 0
Concealed site 7 Private - Urban
Recruitment hospital [11] 0 0
Concealed site 15 Public - Rural
Recruitment hospital [12] 0 0
Concealed site 13 Private - Urban
Recruitment hospital [13] 0 0
Concealed site 14 Public - Urban
Recruitment hospital [14] 0 0
Concealed site 12 Private - Urban
Recruitment hospital [15] 0 0
Concealed site 11 Private - Urban
Recruitment hospital [16] 0 0
Concealed site 9 Private - Melbourne
Recruitment hospital [17] 0 0
Concealed site 10 Public - Urban
Recruitment hospital [18] 0 0
Concealed site 18 - 2 Public sites - Urban
Recruitment postcode(s) [1] 0 0
- Rural
Recruitment postcode(s) [2] 0 0
- Semi Rural
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Urban
Recruitment postcode(s) [5] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary total knee or total hip replacement surgeries are costly high volume procedures \& outcomes may be affected by surgical \& care processes \& individual patient characteristics. The primary hypotheses is that non compliance with recommended practice impacts patient outcomes (e.g. the likelihood of complications following surgery). The primary aims of the study are to evaluate the links between processes \& outcomes \& if possible develop a model that will improve patient outcomes \& reduce unnecessary practice variation whilst considering costs.
Trial website
https://clinicaltrials.gov/study/NCT01899443
Trial related presentations / publications
Johns N, Naylor J, McKenzie D, Brady B, Olver J. Is inpatient rehabilitation a predictor of a lower incidence of persistent knee pain 3-months following total knee replacement? A retrospective, observational study. BMC Musculoskelet Disord. 2022 Sep 12;23(1):855. doi: 10.1186/s12891-022-05800-0.
Naylor JM, Hart A, Mittal R, Harris IA, Xuan W. The effectiveness of inpatient rehabilitation after uncomplicated total hip arthroplasty: a propensity score matched cohort. BMC Musculoskelet Disord. 2018 Jul 18;19(1):236. doi: 10.1186/s12891-018-2134-3.
Public notes

Contacts
Principal investigator
Name 0 0
Justine M Naylor, PhD,BAppSc (Phty)
Address 0 0
Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01899443