Large Head X3 Study

NCT02543437 | Unknown Results

• 1 other identifier: SJCR-OR-1002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the Stryker computerized tomography (CT) based Navigation system. Another aspect of this study is to observe wear resistance performance of X3 over historical liner existing highly crosslinked polyethylene.

Conditions

Degenerative Joint Disease

Outcome Measures

Primary Outcomes (2)

• Range of Motion(ROM) (Degree)

  Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.

  Intraoperative

• Lift Off Distance in Dislocation Maneuver(mm)

  Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.

  Intraoperative

Secondary Outcomes (1)

• Wear Rate(%)

  1 year, 2 years, 3 years and 5 years after surgery

Study Arms (1)

Trident Acetabular X3 Insert

OTHER

28mm, 32mm and 36mm liner

Device: Trident Acetabular X3 Insert

Interventions

Trident Acetabular X3 Insert DEVICE

Trident Acetabular X3 Insert

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who is a candidate for primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
• Patient who has diagnosis of degenerative joint disease and no bacterial infectious disease.
• Patient whose age is 20 or over.
• Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
• Patient who is willing and able to comply with postoperative scheduled evaluations.

You may not qualify if:

• Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
• Patient who requires revision surgery of a previously implanted total hip arthroplasty.
• Patient who is morbidly obese, defined as having a Body Mass Index (BMI) \> 45.
• Patient who is or may be pregnant female.
• Patient who has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
• Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
• Patient who is immunologically suppressed or receiving chronic steroids.
• Patient who is judged ineligible with specific reason by primary doctor.

Sponsors & Collaborators

• Stryker Japan K.K.: lead

Study Sites (4)

Nagoya Kyoritsu Hospital

Nagoya, Aichi-ken, 454-0933, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Kyowakai Hospital.

Suita, Osaka, 564-0001, Japan

Location

Osaka City General Hospital.

Osaka, 534-0021, Japan

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Results Point of Contact

• Title: Yasuyuki Inatsugu, Associate manager of clinical affairs
• Organization: Stryker Japan

yasuyuki.inatsugu@stryker.com

81 3 6894 8394

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: September 7, 2015
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2019
• Last Updated: October 15, 2018
• Results First Posted: April 6, 2016

Record last verified: 2018-09

Locations

JP (4)