Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2027-04-30

Brief Summary

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The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

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THA with G7 PPS coted acetabular component

Intervention Type DEVICE

THA with G7 OsseoTi coted acetabular component

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.

* Participants must be 18-75 years of age.
* Participants must be able to speak and understand Danish (or depending on country where patient is enrolled).
* Participants must be able to give informed consent and be cognitively intact.
* Participants must be expected to be able to complete all postoperative controls.
* Participants must not have severe comorbidities, ASA-score ≤ 3.

Exclusion Criteria

* Terminal illness.
* Rheumatoid arthritis.
* Previous fracture of the hip.
* Osteonecrosis of the hip.
* Previous infection of the hip.
* Severe bony deformity warranting the use of non-standard implants.
* Metastasis in the periarticular bone or proximal femur.
* Female patients that are pregnant or planning pregnancy during follow-up period
* If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation.
* Documented osteoporosis with patient in active medical treatment.
* Comorbidity with altered pain perception (e.g. DM with neuropathy).
* Participants that develop deep infection in the follow-up period are excluded from the project.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No