Evaluate E1 Wear, Clinical Performance of E1 Liner in THA... | NCT02087449

Studies
Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population

NCT02087449

Sponsor

Zimmer Biomet

Status

Terminated

Last Update Posted

Apr 2, 2025Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Osteoarthritis
Avascular Necrosis
Traumatic Arthritis
Rheumatoid Arthritis
Legg-perthes Disease

Interventions

E1-Hip Bearing

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decided to terminate study.

Expanded Access Info

Start Date

Feb 2013Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 12, 2024Actual

First Submitted Date

Mar 5, 2014

First Submission Date that Met QC Criteria

Mar 13, 2014

First Posted Date

Mar 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2025

Last Update Posted Date

Apr 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population

Detailed Description

Total hip arthroplasty (THA) is one of the most successful surgical procedures in general. Yet, a few problems remain unsolved, and aseptic loosening is probably the most important of them. One of the main reasons for aseptic loosening in THA is the foreign body reaction caused by the wear particles. Since the late 1990s, the orthopedic industry has been developing highly crosslinked polyethylene (HXLPE) materials to capitalize on the increased wear resistance. In 2007, E1® Antioxidant Infused Technology was developed to reduce wear rate, maintain mechanical properties and prevent oxidative degradation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
E1-Hip Bearing		E1-Hip Bearing, Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population	Device: E1-Hip Bearing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E1-Hip Bearing	Device	Vitamin E doping of highly cross-linked polyethylene is a proposed method for insuring long-term oxidative stability of highly cross-linked ultra-high molecular weight polyethylene for use in total joint arthroplasty. In vitro research and development studies have shown that this material has improved wear performance, retention of mechanical properties, and a high resistance to oxidation due to the anti-oxidative properties of Vitamin E.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HHS score	Comparison in clinical outcomes scores between preoperative and various postoperative time points	1 year

Secondary Outcomes

Measure	Description	Time Frame
Hip Functions	Harris Hip Score at post follow-up visit	6 Months
EQ5D	Standardised instrument for use as a measure of health outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients will be included in this study if they received Ringloc acetabular system with E1 liner per the approved indications for use by KFDA in Korea. Specifically,

Osteoarthritis
Avascular necrosis
Legg Perthes
Rheumatoid Arthritis
Diastrophic variant
Fracture of the pelvis
Fused hip
Slipped capital epiphysis
Subcapital fractures
Traumatic arthritis Patients aged over 20 Patients with limited co-morbidity - ASA I - III

Exclusion Criteria:

Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Ringloc acetabular system with E1 liner. These indications are stated below:

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,
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who are treated to have Total Hip Arthroplasty at Daegu Catholic University Hospital, Kyung Pook Nat'l Univ. Hospital, Yeonsei Univ. College of Medicine, and Gangdong Kyung Hee Univ. Hospital

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Shin Yoon Kim, PHD	Kyung Pook Nat'l Univ. Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kyungpook National University Hospital		Daegu	Kyungsangbuk-do	700-721	South Korea

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 22, 2015	Jun 21, 2018	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D010020	Osteonecrosis
D001172	Arthritis, Rheumatoid
D007873	Legg-Calve-Perthes Disease

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided