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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: THA with G7 PPS coted acetabular component; Device: THA with G7 OsseoTi coted acetabular component

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
• Sweden
  • Gothenburg, Sweden, SW-431 80
    • Sahlgrenska University Hospital, Department of Orthopedics,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OsseoTi™ G7 large; OsseoTi™ G7 acetabular cup and an E1™ liner holding largest possible femoral head (36mm-44mm)	Device: THA with G7 PPS coted acetabular component; Device: THA with G7 OsseoTi coted acetabular component
Active Comparator: OsseoTi™ G7 32; OsseoTi™ G7 acetabular cup and an E1™ insert holding a 32mm femoral head	Device: THA with G7 PPS coted acetabular component; Device: THA with G7 OsseoTi coted acetabular component
Active Comparator: conventional PPS coated G7 large; conventional PPS coated G7 acetabular cup and an E1™ insert holding largest possible femoral head (36mm-44mm)	Device: THA with G7 PPS coted acetabular component; Device: THA with G7 OsseoTi coted acetabular component
Active Comparator: conventional PPS coated G7 32; conventional PPS coated G7 acetabular cup and an E1™ insert holding a 32mm femoral head	Device: THA with G7 PPS coted acetabular component; Device: THA with G7 OsseoTi coted acetabular component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Anticipated): April 1, 2027

Study Registration Dates

• First Submitted: December 6, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Parasympathomimetics; Tacrine
• Other Study ID Numbers: G7_RSA_v1.02