A Register Based Prospective Study During Implementation of a New Cup

NCT ID: NCT04350255

Last Updated: 2022-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2030-08-01

Brief Summary

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In a prospective register-based study, we aim to evaluate the implant survival, clinical outcomes and X-ray findings by following a cohort of patients operated with the Trident II cup.

Detailed Description

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Data will be collected from a cohort consisting of minimum 500 total hip arthroplasties. The patients will be recruited from multiple high volume centers in Sweden. To determine if there is evidence of inferiority as per benchmarking recommendations by The Orthopaedic Data Evaluation Panel the following parameters will be studied: Clinical parameters such as EQ-5D, Oxford Hip Score and Forgotten Joint Score, preoperative and after 1, 3, 6 and 10 years. Conventional radiography will be done preoperatively, postoperatively, 3, 6 and 10 years after total hip replacement. CTMA will be done postoperatively, 3 and 6 month and 2 years after total hip replacement.

Conditions

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Prospective

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trident II Hemispherical cup (Stryker Orthopaedics)

Total hip arthroplasty using non cemented Trident II Hemispherical acetabular cup

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type DEVICE

Total hip arthroplasty with a Trident II hemispherical cup

Total hip arthroplasty

Intervention Type DEVICE

Total hip arthroplasty with a Trident II Tritanium cup

Trident II Tritanium cup (Stryker Orthopaedics)

Total hip arthroplasty using non cemented Trident II Tritanium acetabular cup

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type DEVICE

Total hip arthroplasty with a Trident II hemispherical cup

Total hip arthroplasty

Intervention Type DEVICE

Total hip arthroplasty with a Trident II Tritanium cup

Interventions

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Total hip arthroplasty

Total hip arthroplasty with a Trident II hemispherical cup

Intervention Type DEVICE

Total hip arthroplasty

Total hip arthroplasty with a Trident II Tritanium cup

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary hip replacement
* Eligible for uncemented fixation of the acetabular component
* Suitable for one of the stem designs from Stryker Orthopaedics
* Accepts follow-up according to the study protocol

Exclusion Criteria

* Difficulties to understand written information due to language problems or other reasons
* Use of augments needed
* Acute hip fracture
* Tumor in the hip joint
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stryker Nordic

INDUSTRY

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maziar Mohaddes Ardebili

Sahlgrenska University Hospital, Sweden

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Orthopaedics

Mölndal, Västra Götaland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Maziar Mohaddes, MD, PhD

Role: CONTACT

+46730701147

Adam Rosenbaum, MD

Role: CONTACT

+46705330149

Other Identifiers

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STEISURE - Trident II

Identifier Type: -

Identifier Source: org_study_id

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