Arthropathy of HipNCT01103882

Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing

An observational study of Arthropathy of Hip, run by Zimmer Biomet at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objectives of this clinical study include: Assess the rate of dislocation and fracture of THA using the new (the 4th generation) ceramic implants. Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation) composite ceramic bearing. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Arthropathy of Hip
How many people: 277 participants
Where: 4 sitesSouth Korea
Study dates: May 2010to Dec 2017
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients indicated for total hip arthroplasty

Who may be able to join

Patients suitable for primary Total Hip Replacement
Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
Osteoarthritis
Avascular necrosis
Legg Perthes
Rheumatoid Arthritis

Show all 14Show fewer

Diastrophic variant
Fracture of the pelvis
Fused hip
Slipped capital epiphysis
Subcapital fractures
Traumatic arthritis
Patients aged over 20
Patients must be able to understand instructions and be willing to return for follow-up

Who cannot join

Absolute contraindications include: infection, sepsis, and osteomyelitis
Relative contraindications include:
uncooperative patient or patient with neurologic disorders who are incapable of following directions,
osteoporosis,
metabolic disorders which may impair bone formation,
osteomalacia,

Show all 10Show fewer

distant foci of infections which may spread to the implant site,
rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
vascular insufficiency, muscular atrophy, or neuromuscular disease.
pregnancy

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

Hallym University Hospital
Anyang
Seoul National University Bundang Hospital
Gyeonggi-do
Murup Hospital
Masan
Chung-Ang University Hospital
Seoul

Other trials in South Korea

About this study

Official title: Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing

The primary objectives of this clinical study include:

Assess the rate of dislocation and fracture of THA using the new (the 4th generation) ceramic implants.
Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation) composite ceramic bearing.
Investigate the performance of the 4th generation ceramic implants mostly in patients younger than 50 years.
Compare the preoperative and postoperative scores of Harris Hip Score, UCLA Activity Score and WOMAC.

Read the detailed description

This study will evaluate incidence of dislocation and short-term clinical outcome on patients who undergo large diameter 4th generation ceramic bearing total hip Arthroplasty ("THA") in comparison to historical data on 3rd generation CoC THA (28mm) patients. Specifically the study intends to address the following research topics:

The incidence of dislocation after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing.
The incidence of ceramic fracture after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing
The survival rate, wear rate, and incidence of osteolysis of THA with use of the 4th generation Ceramic Bearing
Range of motion improvement from preoperative to postoperative to support Korean sitting style after THA with use of the 4th generation Ceramic Bearing.
Clinical outcomes, activity level and QoL of patients with use of the 4th generation Ceramic Bearing.
The performance of THA with use of the new ceramic bearing mostly in patients younger than 50 years.

Conditions: Arthropathy of Hip

What is being measured

The primary outcome is the main question the study is designed to answer.

Dislocation
Number of dislocations
Measured: 12 month postop

Secondary outcomes (1)

Clinical Outcomes
Harris Hip Score, UCLA and WOMAC
Measured: 12 months, 18 months and 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Dec 2017

First posted15 Apr 2010 (estimated)
Study startMay 2010
Primary completionAug 2014
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arthropathy of HipStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
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: Cohort
Time perspective: Prospective
Enrolment: 277 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01103882
Sponsor's protocol ID: INT.CR.LKR1.10
Status last verified: Jun 2018
First submitted: 13 Apr 2010
Last updated: 26 Jun 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis

All Arthropathy of Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing
ClinicalTrials.gov ID: NCT01103882
Acronym / sponsor ID: INT.CR.LKR1.10
Conditions: Arthropathy of Hip
Study type: Observational
Recruitment status: Completed
Enrolment: 277 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Aug 2014 (actual)
Study completion: Dec 2017 (actual)
First posted: 15 Apr 2010 (estimated)
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 primary objectives of this clinical study include:

Assess the rate of dislocation and fracture of THA using the new (the 4th generation) ceramic implants.
Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation) composite ceramic bearing.
Investigate the performance of the 4th generation ceramic implants mostly in patients younger than 50 years.
Compare the preoperative and postoperative scores of Harris Hip Score, UCLA Activity Score and WOMAC.

Detailed description

The incidence of dislocation after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing.
The incidence of ceramic fracture after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing
The survival rate, wear rate, and incidence of osteolysis of THA with use of the 4th generation Ceramic Bearing
Range of motion improvement from preoperative to postoperative to support Korean sitting style after THA with use of the 4th generation Ceramic Bearing.
Clinical outcomes, activity level and QoL of patients with use of the 4th generation Ceramic Bearing.
The performance of THA with use of the new ceramic bearing mostly in patients younger than 50 years.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients indicated for total hip arthroplasty

Key inclusion criteria (14 listed)

Patients suitable for primary Total Hip Replacement
Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
Patients aged over 20
Patients must be able to understand instructions and be willing to return for follow-up

Key exclusion criteria (10 listed)

Absolute contraindications include: infection, sepsis, and osteomyelitis
Relative contraindications include:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Dislocation
Time frame: 12 month postop
Number of dislocations

1 secondary outcome

Clinical Outcomes
Time frame: 12 months, 18 months and 30 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
Individual participant dataSharing planned: No

Related trials for Arthropathy of Hip

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis

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.

Woon-Hwa Jung, M.D. principal investigator

Murup Hospital, Masan, Korea

Yong-Chan Ha, M.D., Ph.D. principal investigator

Chung-Ang University Hospital

Yong-Kyun Lee, M.D., Ph.D. principal investigator

Seoul National University Bundang Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthropathy of Hip, run by Zimmer Biomet at 4 sites in South Korea.

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 14 inclusion and 10 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: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dislocation (time frame: 12 month postop). 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 NCT01103882.

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 26 Jun 2018.