Inpatient vs Outpatient Total Hip Replacement

NCT03026764 | Completed

• 1 other identifier: 106362
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pragmatic randomized clinical trial comparing standard inpatient total hip arthroplasty with same day discharge. Patients who are medically well and have a good support structure at home will be randomized to inpatient or same day discharge. The investigators will compare patient costs from the perspective of the Ministry of Health, the institution, society and the patient. The investigators will also record complications, patient satisfaction, functional ability and quality of life.

Conditions

Osteoarthritis

Keywords

cost; total hip replacement; outpatient Surgery; satisfaction; arthroplasty

Outcome Measures

Primary Outcomes (3)

• Indirect and Direct Costs of Treatment

  ER visits, clinician visits, caregiver lost productivity, tests, etc

  3 months

• Early complications and adverse events

  falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc

  3 months

• Standardized measure of health outcome (EQ-5D)

  utility

  3 months

Secondary Outcomes (7)

• Patient Satisfaction Questionnaire

  3 months

• Western Ontario McMaster Osteoarthritis Index (WOMAC)

  3 months

• Harris Hip Score

  3 months

• Short Form - 12

  3 months

• Pain Numeric Scale Rating

  3 months

Study Arms (2)

Outpatient

EXPERIMENTAL

Patients in the outpatient group (same day discharge following THA) are discharged the same day following surgery. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).

Procedure: Outpatient

Inpatient

ACTIVE COMPARATOR

Patients in the inpatient group (following day discharge following THA) stay in the hospital overnight and then are discharged home the next day. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).

Procedure: Inpatient

Interventions

Outpatient PROCEDURE

Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total hip arthroplasty

Outpatient

Inpatient PROCEDURE

Patients in the inpatient group will be discharged from the hospital the following day after a total hip arthroplasty

Inpatient

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiologists (ASA) score equal to or less than 3
• Have the ability to read and understand English (printed instructions are provided in English only)
• Live within a 60 minute driving distance of University Hospital (UH)
• Home / cell phone access
• An adult to accompany patient home post-operatively
• Sufficient caregiver support

You may not qualify if:

• Patient has significant pain management issues
• Patient / family history of anesthesia related complication(s) (e.g., malignant hyperthermia, pseudocholinesterase deficiency, airway difficulties, obstructive sleep apnea)
• Obesity that significantly impacts the patient's ability to mobilize
• Anaphylaxis to penicillin
• Significant psycho / social issues that would prevent the patient from managing at home safely
• Cognitive issues that preclude the ability to understand instructions
• Lack of an appropriate social network that can observe the patient post-operatively

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (17)

• Aynardi M, Post Z, Ong A, Orozco F, Sukin DC. Outpatient surgery as a means of cost reduction in total hip arthroplasty: a case-control study. HSS J. 2014 Oct;10(3):252-5. doi: 10.1007/s11420-014-9401-0. Epub 2014 Jul 12.

  PMID: 25264442 BACKGROUND

• Berger RA. Total hip arthroplasty using the minimally invasive two-incision approach. Clin Orthop Relat Res. 2003 Dec;(417):232-41. doi: 10.1097/01.blo.0000096828.67494.95.

  PMID: 14646722 BACKGROUND

• Berger RA, Jacobs JJ, Meneghini RM, Della Valle C, Paprosky W, Rosenberg AG. Rapid rehabilitation and recovery with minimally invasive total hip arthroplasty. Clin Orthop Relat Res. 2004 Dec;(429):239-47. doi: 10.1097/01.blo.0000150127.80647.80.

  PMID: 15577494 BACKGROUND

• Berger RA. A comprehensive approach to outpatient total hip arthroplasty. Am J Orthop (Belle Mead NJ). 2007 Sep;36(9 Suppl):4-5.

  PMID: 17948159 BACKGROUND

• Bertin KC. Minimally invasive outpatient total hip arthroplasty: a financial analysis. Clin Orthop Relat Res. 2005 Jun;(435):154-63. doi: 10.1097/01.blo.0000157173.22995.cf.

  PMID: 15930933 BACKGROUND

• Charnley J. Present status of total hip replacement. Ann Rheum Dis. 1971 Nov;30(6):560-4. doi: 10.1136/ard.30.6.560. No abstract available.

  PMID: 5130137 BACKGROUND

• Dorr LD, Maheshwari AV, Long WT, Wan Z, Sirianni LE. Early pain relief and function after posterior minimally invasive and conventional total hip arthroplasty. A prospective, randomized, blinded study. J Bone Joint Surg Am. 2007 Jun;89(6):1153-60. doi: 10.2106/JBJS.F.00940.

  PMID: 17545416 BACKGROUND

• Dorr LD, Thomas D, Long WT, Polatin PB, Sirianni LE. Psychologic reasons for patients preferring minimally invasive total hip arthroplasty. Clin Orthop Relat Res. 2007 May;458:94-100. doi: 10.1097/BLO.0b013e31803212dc.

  PMID: 17224839 BACKGROUND

• Dorr LD, Thomas DJ, Zhu J, Dastane M, Chao L, Long WT. Outpatient total hip arthroplasty. J Arthroplasty. 2010 Jun;25(4):501-6. doi: 10.1016/j.arth.2009.06.005. Epub 2009 Jul 28.

  PMID: 19640672 BACKGROUND

• Husted H, Holm G, Jacobsen S. Predictors of length of stay and patient satisfaction after hip and knee replacement surgery: fast-track experience in 712 patients. Acta Orthop. 2008 Apr;79(2):168-73. doi: 10.1080/17453670710014941.

  PMID: 18484241 BACKGROUND

• Krywulak SA, Mohtadi NG, Russell ML, Sasyniuk TM. Patient satisfaction with inpatient versus outpatient reconstruction of the anterior cruciate ligament: a randomized clinical trial. Can J Surg. 2005 Jun;48(3):201-6.

  PMID: 16013623 BACKGROUND

• Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.

  PMID: 9195314 BACKGROUND

• Lovell TP. Single-incision direct anterior approach for total hip arthroplasty using a standard operating table. J Arthroplasty. 2008 Oct;23(7 Suppl):64-8. doi: 10.1016/j.arth.2008.06.027.

  PMID: 18922376 BACKGROUND

• Mears DC, Mears SC, Chelly JE, Dai F, Vulakovich KL. THA with a minimally invasive technique, multi-modal anesthesia, and home rehabilitation: factors associated with early discharge? Clin Orthop Relat Res. 2009 Jun;467(6):1412-7. doi: 10.1007/s11999-009-0785-y. Epub 2009 Mar 20.

  PMID: 19301081 BACKGROUND

• Chen D, Berger RA. Outpatient minimally invasive total hip arthroplasty via a modified Watson-Jones approach: technique and results. Instr Course Lect. 2013;62:229-36.

  PMID: 23395028 BACKGROUND

• Zomar BO, Marsh JD, Bryant DM, Lanting BA. The cost of outpatient versus inpatient total hip arthroplasty: a randomized trial. Can J Surg. 2022 Sep 1;65(5):E553-E561. doi: 10.1503/cjs.003821. Print 2022 Sep-Oct.

  PMID: 36302128 DERIVED

• Zomar BO, Marsh JD, Lanting BA, Bryant DM. A protocol for a randomized controlled trial investigating the safety and cost-effectiveness of outpatient total hip arthroplasty. BMC Musculoskelet Disord. 2020 Oct 8;21(1):663. doi: 10.1186/s12891-020-03699-z.

  PMID: 33032566 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Personal Satisfaction

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Brent Lanting, MD, FRCSC

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: January 20, 2017
• Study Start: May 1, 2015
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: August 19, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)