Improving Services and Outcomes for Joint Replacement Patients

NCT01899443 | Completed

• 1 other identifier: ISOAJRS_AU
• Study Type: observational
• Target: 1,900
• Locations: 1 country
• Sites: 18

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.

Conditions

Osteoarthritis

Keywords

total hip replacement; total knee replacement; patient outcomes; health services research

Outcome Measures

Primary Outcomes (1)

• Percentage of participants experiencing the composite outcome up to 35 days post surgery.

  The proportion of patients in each group (compliant and non-compliant groups) that experience one or more of the following outcomes - death, readmission, reoperation or surgical complication - up to 35 days post-surgery. Analyses will adjust for patient and service provider confounders.

  35 days post total hip or knee replacement surgery

Secondary Outcomes (8)

• Patient-reported quality of life

  35 days post surgery

• Incidence of venous thromboembolism

  90 days post surgery

• Incidence of deep infection.

  365 days post surgery

• Costs of care processes

  90 days post surgery

• Patient reported quality of life (QoL)

  90 days post surgery

Other Outcomes (1)

• Day of first ambulation attempt post surgery

  day 0-14 post-surgery

Study Arms (1)

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: Observation

Interventions

Observation OTHER

This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.

Total hip and knee replacement patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing primary total hip or knee replacement in private or public hsopitals in Australia

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment / history of dementia
• Hip replacement for fracture
• Revision of previous joint replacement
• Under 18 years of age

Sponsors & Collaborators

• South West Sydney Local Health District: lead

Study Sites (18)

Concealed site 4 Public

Rural, New South Wales, Australia

Location

Concealed site 6 Private

Rural, New South Wales, Australia

Location

Concealed site 8 Private

Rural, New South Wales, Australia

Location

Concealed site 16 Public

Semi Rural, New South Wales, Australia

Location

Concealed site 1 Public

Sydney, New South Wales, Australia

Location

Concealed site 17 Private

Sydney, New South Wales, Australia

Location

Concealed site 2 Public

Sydney, New South Wales, Australia

Location

Concealed Site 3 Public

Sydney, New South Wales, Australia

Location

Concealed site 5 Private

Sydney, New South Wales, Australia

Location

Concealed site 7 Private

Urban, New South Wales, Australia

Location

Concealed site 15 Public

Rural, Queensland, Australia

Location

Concealed site 13 Private

Urban, Queensland, Australia

Location

Concealed site 14 Public

Urban, Queensland, Australia

Location

Concealed site 12 Private

Urban, South Australia, Australia

Location

Concealed site 11 Private

Urban, Tasmania, Australia

Location

Concealed site 9 Private

Melbourne, Victoria, Australia

Location

Concealed site 10 Public

Urban, Victoria, Australia

Location

Concealed site 18 - 2 Public sites

Urban, Victoria, Australia

Location

Related Publications (5)

• Johns N, Naylor J, McKenzie D, Brady B, Olver J. High pain reported at 3 months post-total knee arthroplasty often persists for the next 3 years and is associated with reduced function and quality of life. Musculoskeletal Care. 2024 Mar;22(1):e1866. doi: 10.1002/msc.1866.

  PMID: 38348944 DERIVED

• Sidhu V, Badge H, Churches T, Maree Naylor J, Adie S, A Harris I. Comparative effectiveness of aspirin for symptomatic venous thromboembolism prophylaxis in patients undergoing total joint arthroplasty, a cohort study. BMC Musculoskelet Disord. 2023 Aug 3;24(1):629. doi: 10.1186/s12891-023-06750-x.

  PMID: 37537580 DERIVED

• Jenkin DE, Harris IA, Descallar J, Naylor JM. Discharge to inpatient rehabilitation following arthroplasty is a strong predictor of persistent opioid use 90 days after surgery: a prospective, observational study. BMC Musculoskelet Disord. 2023 Jan 14;24(1):31. doi: 10.1186/s12891-023-06142-1.

  PMID: 36639624 DERIVED

• 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.

  PMID: 36096816 DERIVED

• 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.

  PMID: 30021552 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Observation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Justine M Naylor, PhD,BAppSc (Phty)

  Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research

  PRINCIPAL INVESTIGATOR

• Ian A Harris, PhD,MBBS

  Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research

  PRINCIPAL INVESTIGATOR

• Helen M Badge, MApSc,BAScOT

  Ingham Institute for Applied Medical Research, University of NSW

  PRINCIPAL INVESTIGATOR

• Wei Xuan, PhD

  Ingham Institute Applied Medical Research

  PRINCIPAL INVESTIGATOR

• Christine Lin, PhD, BApScPhty

  George Institute, University of Syndey, Australia

  PRINCIPAL INVESTIGATOR

• Elizabeth Armstrong, BAppScPhty

  University of NSW, Sydney, Australia

  PRINCIPAL INVESTIGATOR

• Kevin Bozic, MD MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• John Fletcher, PhD, MBBS

  University of Sydney, Australia

  PRINCIPAL INVESTIGATOR

• Iain Gosbell, PhD, MBBS

  University of Western Sydney, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Principal Research Fellow; Director

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 15, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

AU (18)