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

Hvidovre University Hospital

Status: Active, not recruiting

Conditions: Osteoarthritis

Treatments: Device: THA with G7 OsseoTi coted acetabular component; Device: THA with G7 PPS coted acetabular component

Study type: Interventional

Funder types: Other

Identifiers

NCT02316704

G7_RSA_v1.02

Details and patient eligibility

About

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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 4 patient groups

OsseoTi™ G7 large

Active Comparator group

Description:

OsseoTi™ G7 acetabular cup and an E1™ liner holding largest possible femoral head (36mm-44mm)

Treatment:

Device: THA with G7 PPS coted acetabular component

Device: THA with G7 OsseoTi coted acetabular component

OsseoTi™ G7 32

Active Comparator group

Description:

OsseoTi™ G7 acetabular cup and an E1™ insert holding a 32mm femoral head

Treatment:

Device: THA with G7 PPS coted acetabular component

Device: THA with G7 OsseoTi coted acetabular component

conventional PPS coated G7 large

Active Comparator group

Description:

conventional PPS coated G7 acetabular cup and an E1™ insert holding largest possible femoral head (36mm-44mm)

Treatment:

Device: THA with G7 PPS coted acetabular component

Device: THA with G7 OsseoTi coted acetabular component

conventional PPS coated G7 32

Active Comparator group

Description:

conventional PPS coated G7 acetabular cup and an E1™ insert holding a 32mm femoral head

Treatment:

Device: THA with G7 PPS coted acetabular component

Device: THA with G7 OsseoTi coted acetabular component