Total Hip ReplacementTHRNCT03120312
Short Term and Long Term Outcome for Elderly Patients Treated With Total Hip Replacement
An observational study of Total Hip Replacement, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial summary
The is a retrospective analysis to study the characteristics of elderly patients treated with total hip replacements during past 5 years． Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- total hip replacement
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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．
Who may be able to join
- ASA Ⅱ-Ⅲ,elective operation patients，
- NO other severe complication history
Who cannot join
- Having severe comorbidity
- not for the first time of joint replacement
- Suffered from neurologic disorder or impaired mental state
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zheng Guo
Taiyuan, Shanxi, 030001
Zheng Guo, MB，PhD, +863513365790, guozheng713@yahoo.com
Weijun Liang, MSc, +863513365790, weijun_liang@126.com
About this study
Official title: Short Term and Long Term Outcome for Elderly Patients Treated With Total Hip Replacements During Past 5 Years :A Retrospective Analysis
The is a retrospective analysis to study the characteristics of elderly patients treated with total hip replacements during past 5 years．
Read the detailed description
Patients underwent total hip replacement due to removal of the hip caused by retrogressive lesions, is conducive to the improvement of hip function .But at the same time,the complications from patients accepted total hip replacement surgery will directly or indirectly affect the prognosis of the patients, resulting in patients with delayed recovery and increase the hospitalization time and cost. Serious complications can lead to patients deaths during perioperative period. This study was designed to provide a retrospective analysis of postoperative recovery, quality of life, and complications in patients undergoing hip replacement over the past five years, providing data for clinical studies.
- Conditions
- Total Hip Replacement
- Being tested
- total hip replacement
- Keywords
- outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip replacementProcedure or surgery
primary hip replacement patients during past 5 years．
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (2)
The incidence of postoperative complications
Participants will be followed for the incidence of postoperative complications
Measured: from 7 days to 1 year
Mortality during 5 years after surgery
Participants will be followed for Survival rate during 5 years after surgery
Measured: during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start30 Oct 2020
- Primary completion30 Jun 2023
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
- Investigators
- Zheng Guo, Study chair, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120312
- Sponsor's protocol ID
- ZGuo
- Acronym
- THR
- Status last verified
- Jan 2024
- First submitted
- 15 Apr 2017
- Last updated
- 25 Jan 2024
- Results posted
- No
Publications
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.
PubMed 18772476Foss 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.
PubMed 17054955Singh 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.
PubMed 22021865Krecisz 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.
PubMed 23212287Deutman 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.
PubMed 908716
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term and Long Term Outcome for Elderly Patients Treated With Total Hip Replacements During Past 5 Years :A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03120312
- Acronym / sponsor ID
- THR / ZGuo
- Conditions
- Total Hip Replacement
- Keywords
- outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The is a retrospective analysis to study the characteristics of elderly patients treated with total hip replacements during past 5 years．
Detailed description
Patients underwent total hip replacement due to removal of the hip caused by retrogressive lesions, is conducive to the improvement of hip function .But at the same time,the complications from patients accepted total hip replacement surgery will directly or indirectly affect the prognosis of the patients, resulting in patients with delayed recovery and increase the hospitalization time and cost. Serious complications can lead to patients deaths during perioperative period. This study was designed to provide a retrospective analysis of postoperative recovery, quality of life, and complications in patients undergoing hip replacement over the past five years, providing data for clinical studies.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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．
Key inclusion criteria (2 listed)
- ASA Ⅱ-Ⅲ,elective operation patients，
- NO other severe complication history
Key exclusion criteria (3 listed)
- Having severe comorbidity
- not for the first time of joint replacement
- Suffered from neurologic disorder or impaired mental state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total hip replacementprimary hip replacement patients during past 5 years． | Procedure or surgery | – |
Primary outcome
Quality of life during 5 years after surgery
Time frame: 5 years
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
2 secondary outcomes
The incidence of postoperative complications
Time frame: from 7 days to 1 year
Mortality during 5 years after surgery
Time frame: during 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Background: PubMed 18772476Penrod 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.
- Background: PubMed 17054955Foss 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.
- Background: PubMed 22021865Singh 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.
- Background: PubMed 23212287Krecisz 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.
- Background: PubMed 908716Deutman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zheng Guo study chair
Second Hospital of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Replacement, run by Second Hospital of Shanxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Guo (89351-3365790, guozheng713@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life during 5 years after surgery (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120312, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.