NCT03120312

Brief Summary

The is a retrospective analysis to study the characteristics of elderly patients treated with total hip replacements during past 5 years.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
3.5 years until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

April 15, 2017

Last Update Submit

January 24, 2024

Conditions

Keywords

outcome

Outcome Measures

Primary Outcomes (1)

  • Quality of life during 5 years after surgery

    evaluate the quality of life after surgery by WHO QOL-BREF scale with interview ,WHO QOL-BREF scale includes five aspects: physical, psychological, social, environmental, integrated, divided into five levels

    5 years

Secondary Outcomes (2)

  • The incidence of postoperative complications

    from 7 days to 1 year

  • Mortality during 5 years after surgery

    during 5 years

Interventions

primary hip replacement patients during past 5 years.

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From January 2012 to July 30,2017,approximately 1500 cases of primary hip replacement in this study,including male ,female and bilateral replacements.

You may qualify if:

  • ASA Ⅱ-Ⅲ,elective operation patients,
  • NO other severe complication history

You may not qualify if:

  • Having severe comorbidity
  • not for the first time of joint replacement
  • Suffered from neurologic disorder or impaired mental state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zheng Guo

Taiyuan, Shanxi, 030001, China

RECRUITING

Related Publications (5)

  • Penrod JD, Litke A, Hawkes WG, Magaziner J, Doucette JT, Koval KJ, Silberzweig SB, Egol KA, Siu AL. The association of race, gender, and comorbidity with mortality and function after hip fracture. J Gerontol A Biol Sci Med Sci. 2008 Aug;63(8):867-72. doi: 10.1093/gerona/63.8.867.

    PMID: 18772476BACKGROUND
  • Foss NB, Palm H, Krasheninnikoff M, Kehlet H, Gebuhr P. Impact of surgical complications on length of stay after hip fracture surgery. Injury. 2007 Jul;38(7):780-4. doi: 10.1016/j.injury.2006.08.028. Epub 2006 Oct 19.

    PMID: 17054955BACKGROUND
  • Singh JA, Jensen MR, Harmsen WS, Gabriel SE, Lewallen DG. Cardiac and thromboembolic complications and mortality in patients undergoing total hip and total knee arthroplasty. Ann Rheum Dis. 2011 Dec;70(12):2082-8. doi: 10.1136/ard.2010.148726. Epub 2011 Oct 21.

    PMID: 22021865BACKGROUND
  • Krecisz B, Kiec-Swierczynska M, Chomiczewska-Skora D. Allergy to orthopedic metal implants - a prospective study. Int J Occup Med Environ Health. 2012 Sep;25(4):463-9. doi: 10.2478/S13382-012-0029-3. Epub 2012 Dec 3.

    PMID: 23212287BACKGROUND
  • Deutman R, Mulder TJ, Brian R, Nater JP. Metal sensitivity before and after total hip arthroplasty. J Bone Joint Surg Am. 1977 Oct;59(7):862-5.

    PMID: 908716BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Zheng Guo

    Second Hospital of Shanxi Medical University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2017

First Posted

April 19, 2017

Study Start

October 30, 2020

Primary Completion

June 30, 2023

Study Completion

January 31, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Locations