Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty

Zimmer Biomet

Status: Completed

Conditions: Avascular Necrosis of Hip; Osteoarthritis, Hip; Post-Traumatic Osteoarthritis of Hip; Inflammatory Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT03672916

CME2010-24H

Details and patient eligibility

About

This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.

Full description

The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.

This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System.

A total of 200 patients are planned to be enrolled in this study which will last 12 years (2 year enrollment plus 10 years follow-up) with the follow-up visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.

Enrollment: 185 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is 18 to 75 years of age, inclusive.

• Patient is skeletally mature.

• Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:

  • Avascular necrosis (AVN)
  • Osteoarthritis (OA)
  • Inflammatory arthritis (i.e. Rheumatoid arthritis)
  • Post-traumatic arthritis

• Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).

• Patient has a Harris Hip Score <70 in the affected hip

• Patient is willing and able to provide written informed consent.

• Patient is willing and able to cooperate in the required post-operative therapy.

• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.

• Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent.

Exclusion criteria

• The patient is:

  • A prisoner
  • Mentally incompetent or unable to understand what participation in the study entails
  • A known alcohol or drug abuser
  • Anticipated to be non-compliant.

• The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.

• The patient has a vascular (large and small vessel disease) insufficiency.

• The patient has a neurologic condition in the ipsalateral or contralateral limb which affects lower limb function.

• The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.

• The patient is known to be pregnant.

• The patient is unwilling or unable to give informed consent, or to comply with the follow-up program.

• The patient has received an investigational drug or device within the previous 6 months.

• The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.

• The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock.

• The patient has osteoradionecrosis in the operative hip joint

• The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.

• The patient has known local bone tumors in the operative hip.

• The patient is Grade III obese with a Body Mass Index (BMI) > 40.

Trial design

185 participants in 1 patient group

Patients who received the Allofit IT with BIOLOX delta

Description:

Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the BIOLOX delta Taper Liners