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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

THA with G7 PPS coted acetabular component

Device

THA with G7 OsseoTi coted acetabular component

Device

Primary outcomes

RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.

Time frame: 2 year

Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty: A Single-Blinded Randomized Controlled Trial Evaluating Implant Migration, Acetabular Liner Wear, and Patient Reported Outcome

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2027
First posted: Dec 15, 2014
Registry last updated: Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting