## Protocol Section
### Identification Module
**NCT ID:** NCT06432543

**Brief Title:** Polyethylene Wear Particle Analysis of THA

**Official Title:** Polyethylene Wear Particle Analysis of Total Hip Arthroplasty -International Multicenter Study-

#### Organization Study ID Info
**ID:** OMU 2023-132
#### Organization
**Class:** OTHER
**Full Name:** Osaka Metropolitan University
### Status Module
#### Completion Date
**Date:** 2028-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Mayo Clinic

**Class:** OTHER

**Name:** Hospital for Special Surgery, New York

**Class:** OTHER

**Name:** Istituto Ortopedico Rizzoli

#### Lead Sponsor

**Class:** OTHER

**Name:** Osaka Metropolitan University

#### Responsible Party

**Investigator Affiliation:** Osaka Metropolitan University

**Investigator Full Name:** Yukihide Minoda

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Purpose of research The purpose of this study was to demonstrate that polyethylene (Vitamin E-containing polyethylene), a newly introduced biomaterial for tibial inserts in hip replacement surgery and widely used clinically, but whose mid- to long-term clinical results are still unknown, is superior to conventional polyethylene in vivo. The aim of this project is to conduct an international multi-center joint research study to determine whether polyethylene wear debris production can be reduced in the future, using an in vivo polyethylene wear debris analysis method that the investigators developed as a method that can provide early feedback.

**Detailed Description:** Research method In this study, the investigators conducted the following steps to determine the in vivo wear particles (number, size, and morphology) of conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose mid- to long-term results have not yet been clarified. Clarifying the difference.

Target of this research In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.

First total joint replacement

* 30 patients using polyethylene containing Vitamin E
* 30 patients using conventional polyethylene (no high cross-linking)
* 30 patients using conventional polyethylene (with high cross-linking)

Accumulation of periarticular tissue In this study, the investigators will focus on patients undergoing revision hip arthroplasty as a routine medical treatment.

The test will be conducted after obtaining approval from the ethics committee at each facility and obtaining informed consent. The pericapsular tissue, which is removed during surgery and usually discarded, is obtained and fixed in formalin fixative. The tissue will be transported to the Department of Orthopedic Surgery, Osaka Public University Graduate School of Medicine for analysis. International transportation of tissues requires outsourcing to specialized companies with experience in transporting tissues from overseas.

Isolation of polyethylene wear debris The collected tissue around the joint capsule is immersed in 5Mol sodium hydroxide at 65°C for 1 hour to decompose the protein. Make a sucrose layer (5, 10, 20%) in a 14ml tube (14PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the dissolved solution, and place in an ultracentrifuge (CP100a, P28S1014 rotor, Hitachi Koki). Ultracentrifuge at 28,000 rpm \[103,7009g\] for 3 hours at 4°C. Prepare an isopropanol layer (0.90 and 0.96 g/mL) in a 40 ml tube (40PA tube, Hitachi Koki Co, Ltd, Tokyo, Japan), add the upper layer of sucrose layer, and centrifuge at 28,000 rpm (103,7009 g) and perform ultracentrifugation at 4°C for 1 hour. The isopropanol interlayer is collected to isolate polyethylene wear debris.

Analysis of polyethylene wear debris The isopropanol interlayer is filtered through a 0.1 μm polycarbonate filter (VCTP 013-00, Millipore Corporation, Bedford, MA). Dry the polycarbonate filter, fix it on an aluminum pedestal (M4, Nisshin EM Co, Ltd, Tokyo, Japan), and apply platinum coating (E-1030 ion sputter, Hitachi Science Systems Ltd, Tokyo, Japan). Observe the polyethylene wear particles on the polycarbonate filter using a scanning electron microscope (S4700SI, Hitachi Ltd, Tokyo, Japan), and analyze the following items using an image analyzer (Mac Scope, Mitani Co, Tokyo, Japan).

* Number of polyethylene wear particles (number per 1g of tissue)
* Size (Equivalent circle diameter \[μm\])
* Shape (aspect ratio, roundness)

Comparison of iv vivo polyethylene wear powder morphology depending on polyethylene material The number, size, and form of polyethylene wear debris will be compared between conventional polyethylene, whose long-term results have already been clarified, and vitamin E-containing polyethylene, whose medium- to long-term results have not yet been clarified. The investigators also investigated factors that affect polyethylene wear in vivo (age, height, weight, period from initial surgery to revision surgery, hip joint range of motion, hip prosthesis clinical score \[Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement \[HOOS Jr\], Harris Hip Score, University of California Los Angeles \[UCLA\] activity score\]).

### Conditions Module

**Conditions:**

- Wear of Articular Bearing Surface of Prosthetic Joint

- Hip Arthropathy

**Keywords:**

- Polyethylene wear particle

- Total hip arthroplasty

### Design Module

#### Bio Spec

**Description:** The pericapsular tissue, which is removed during surgery

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** polyethylene containing Vitamin E

**Intervention Names:**

- Device: polyethylene

**Label:** polyethylene containing Vitamin E

#### Arm Group 2

**Description:** conventional polyethylene (no highly cross-linking)

**Intervention Names:**

- Device: polyethylene

**Label:** conventional polyethylene (no highly cross-linking)

#### Arm Group 3

**Description:** conventional polyethylene (with highly cross-linking)

**Intervention Names:**

- Device: polyethylene

**Label:** conventional polyethylene (with highly cross-linking)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- conventional polyethylene (no highly cross-linking)

- conventional polyethylene (with highly cross-linking)

- polyethylene containing Vitamin E

**Description:** No intervention as this is an observational study

**Name:** polyethylene

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** counts / g (tissue sample)

**Measure:** Number of polyethylene wear particles

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** equivalent circle diameter \[㎛\]

**Measure:** Equivalent circle diameter of polyethylene wear particles

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** aspect ratio

**Measure:** Aspect ratio of polyethylene wear particles

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** roundness

**Measure:** Roundness of polyethylene wear particles

**Time Frame:** When tissue sample was collected during THA revision surgery

#### Secondary Outcomes

**Description:** kg/m2

**Measure:** Body mass index

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** Degrees

**Measure:** Hip joint flexion angle

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** Degrees

**Measure:** Hip joint exertion angle

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** Degrees

**Measure:** Hip joint adduction angle

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** Degrees

**Measure:** Hip joint abduction angle

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** 0(worse)-100(best)

**Measure:** Hip dysfunction and Osteoarthritis Outcome. Score for Joint Replacement

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** 0(worse)-100(best)

**Measure:** Harris Hip Score

**Time Frame:** When tissue sample was collected during THA revision surgery

**Description:** １(worse)-10(best)

**Measure:** University of California at Los Angeles activity score

**Time Frame:** When tissue sample was collected during THA revision surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients undergoing revision hip arthroplasty within the study period
2. Patients over 20 years old
3. Patients who have received a sufficient explanation, have sufficient understanding, and have given their free written consent.
4. Patients who have passed 2 years or more since their first total hip arthroplasty

Exclusion Criteria:

1. Patients who are judged to be unsuitable as research subjects by the research physician

**Minimum Age:** 20 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients undergoing revision hip arthroplasty within the study period

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yminoda@omu.ac.jp

**Name:** Yukihide Minoda, MD, PhD

**Phone:** 81-6-6645-3851

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Osaka Metropolitan University

**Name:** Yukihide Minoda, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Iwakiri K, Iwaki H, Kobayashi A, Minoda Y, Kagiyama H, Kadoya Y, Takaoka K. Characteristics of Hylamer polyethylene particles isolated from peri-prosthetic tissues of failed cemented total hip arthroplasties. J Biomed Mater Res B Appl Biomater. 2008 Apr;85(1):125-9. doi: 10.1002/jbm.b.30924.

**PMID:** 17806109

**Citation:** Hata K, Minoda Y, Ikebuchi M, Mizokawa S, Ohta Y, Miyazaki N, Miyake Y, Nakamura H. In vivo wear particles of remelted highly crosslinked polyethylene after total hip arthroplasty: report of four cases. J Mater Sci Mater Med. 2015 Mar;26(3):133. doi: 10.1007/s10856-015-5472-9. Epub 2015 Feb 25.

**PMID:** 25712074

**Citation:** Minoda Y, Kobayashi A, Sakawa A, Aihara M, Tada K, Sugama R, Iwakiri K, Ohashi H, Takaoka K. Wear particle analysis of highly crosslinked polyethylene isolated from a failed total hip arthroplasty. J Biomed Mater Res B Appl Biomater. 2008 Aug;86(2):501-5. doi: 10.1002/jbm.b.31048.

**PMID:** 18360879

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10621

- Name: Joint Diseases

- Relevance: HIGH

- As Found: Arthropathy

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007592

- Term: Joint Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M22972

- Name: Tocopherols

- Relevance: LOW

- As Found: Unknown

- ID: M17553

- Name: Vitamin E

- Relevance: LOW

- As Found: Unknown

- ID: M22975

- Name: Tocotrienols

- Relevance: LOW

- As Found: Unknown

- ID: M22969

- Name: alpha-Tocopherol

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: T466

- Name: Tocopherol

- Relevance: LOW

- As Found: Unknown

- ID: T467

- Name: Tocotrienol

- Relevance: LOW

- As Found: Unknown

- ID: T480

- Name: Vitamin E

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
