Regression Discontinuity Design Search for Differences in Mortality and Revision for Fixation Type of THA

NCT05108155 | Completed

• 1 other identifier: 17011991
• Study Type: observational
• Target: 43,789
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to apply the regression discontinuity design (RD) methodology on arthroplasty registry data. The investigators aim to use an age-based cut-off for fixation type choice and estimate the causal effect of fixation type on short term mortality and revision, using a fuzzy regression discontinuity design.

Conditions

Hip Osteoarthritis

Keywords

Total Hip Arthorplasty; Fixation; Cemented; Uncemented; Regression discontinuity

Outcome Measures

Primary Outcomes (2)

• Number of Participants who die within 90 days after surgery

  Mortality after surgery

  90 days

• Number of Participants who undergo revision surgery of the treated hip

  Number of Participants who undergo revision surgery of the treated hip as recorded in the LROI database.

  2 years

Secondary Outcomes (1)

• Number of Participants who undergo revision surgery of the treated hip

  5 years

Study Arms (1)

THA

Patient with primary total hip arthroplasty

Procedure: Cemented THA; Procedure: Unemented THA

Interventions

Cemented THA PROCEDURE

THA with cement fixation

THA

Unemented THA PROCEDURE

THA with uncemented / pressfit fixation

THA

Eligibility Criteria

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

Study Population

The data will consist of all the THAs done in the aforementioned period in the 94 hospitals who report to the Dutch Arthroplasty Register.

You may qualify if:

• Primary total hip arthroplasty with diagnosis osteoarthritis.
• Placed January 1st 2007 and December 31th 2017
• Patients who are 18 years and older

You may not qualify if:

• Hybrid fixation type (cemented stem and uncemented acetabular component)
• Reverse hybrid fixation type (uncemented stem and cemented acetabular component)
• Metal-on-metal bearing THA

Sponsors & Collaborators

• Leiden University Medical Center: lead
• OLVG: collaborator
• Dijklander Hospital, Hoorn and Purmerend, The Netherlands: collaborator
• Radboud University Medical Centre Nijmegen, Nijmegen, the Netherlands: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

Leiden University Medical Cente

Leiden, South Holland, Netherlands

Location

Related Publications (9)

• Abdulkarim A, Ellanti P, Motterlini N, Fahey T, O'Byrne JM. Cemented versus uncemented fixation in total hip replacement: a systematic review and meta-analysis of randomized controlled trials. Orthop Rev (Pavia). 2013 Mar 15;5(1):e8. doi: 10.4081/or.2013.e8. Print 2013 Feb 22.

  PMID: 23705066 BACKGROUND

• Maloney WJ. National Joint Replacement Registries: has the time come? J Bone Joint Surg Am. 2001 Oct;83(10):1582-5. doi: 10.2106/00004623-200110000-00020. No abstract available.

  PMID: 11679613 BACKGROUND

• Corbett KL, Losina E, Nti AA, Prokopetz JJ, Katz JN. Population-based rates of revision of primary total hip arthroplasty: a systematic review. PLoS One. 2010 Oct 20;5(10):e13520. doi: 10.1371/journal.pone.0013520.

  PMID: 20976011 BACKGROUND

• Laupacis A, Bourne R, Rorabeck C, Feeny D, Tugwell P, Wong C. Comparison of total hip arthroplasty performed with and without cement : a randomized trial. J Bone Joint Surg Am. 2002 Oct;84(10):1823-8. doi: 10.2106/00004623-200210000-00013.

  PMID: 12377914 BACKGROUND

• Makela KT, Matilainen M, Pulkkinen P, Fenstad AM, Havelin L, Engesaeter L, Furnes O, Pedersen AB, Overgaard S, Karrholm J, Malchau H, Garellick G, Ranstam J, Eskelinen A. Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations. BMJ. 2014 Jan 13;348:f7592. doi: 10.1136/bmj.f7592.

  PMID: 24418635 BACKGROUND

• Pringle M, Churchill R. Randomised controlled trials in general practice. BMJ. 1995 Nov 25;311(7017):1382-3. doi: 10.1136/bmj.311.7017.1382. No abstract available.

  PMID: 8520259 BACKGROUND

• Trochim WM, Cappelleri JC. Cutoff assignment strategies for enhancing randomized clinical trials. Control Clin Trials. 1992 Jun;13(3):190-212. doi: 10.1016/0197-2456(92)90003-i.

  PMID: 1320557 BACKGROUND

• Steiner PM, Kim Y, Hall CE, Su D. Graphical Models for Quasi-experimental Designs. Sociol Methods Res. 2017 Mar;46(2):155-188. doi: 10.1177/0049124115582272. Epub 2015 May 14.

  PMID: 30174355 BACKGROUND

• Moscoe E, Bor J, Barnighausen T. Regression discontinuity designs are underutilized in medicine, epidemiology, and public health: a review of current and best practice. J Clin Epidemiol. 2015 Feb;68(2):122-33. doi: 10.1016/j.jclinepi.2014.06.021.

  PMID: 25579639 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: November 4, 2021
• Study Start: January 1, 2007
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

NL (1)