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

Osteoarthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02316704
• Other study ID #: G7_RSA_v1.02
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: April 2027

Study information

• Verified date: February 2021
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: April 2027
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• THA with G7 PPS coted acetabular component

• THA with G7 OsseoTi coted acetabular component

Locations

Country	Name	City	State
Denmark	Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre	Hvidovre
Sweden	Sahlgrenska University Hospital, Department of Orthopedics,	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.	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.	2 year