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Status:

ACTIVE_NOT_RECRUITING

Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study

Lead Sponsor:

Zimmer Biomet

Conditions:

Osteoarthritis

Avascular Necrosis

Eligibility:

All Genders

21-75 years

Brief Summary

The primary objective of this study is to obtain implant survivorship and clinical outcome data for the commercially available Zimmer® Continuum™ Ceramic-on-Ceramic Bearing System when used in primary...

Detailed Description

The subject of this clinical investigation is the Continuum Ceramic Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal™ (TM) Continuum ...

Eligibility Criteria

Inclusion

  • Patient is 21 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

  • 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 chronic renal impairment or failure.
  • The patient has had previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the joint to be operated
  • The patient has a neurologic condition in the ipsolateral 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 undergone a total hip replacement, endoprosthesis, or surface arthroplasty of the contralateral (opposite side) hip within the past 6 months regardless of whether the previous hip was enrolled in this clinical study.
  • 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 had previous girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
  • 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 known local bone tumors and/or cysts in the operative hip.
  • The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
  • The patient is Grade III obese with a Body Mass Index (BMI) \> 35.
  • The patient has osteoradionecrosis in the affected hip joint

Key Trial Info

Start Date :

September 15 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2025

Estimated Enrollment :

203 Patients enrolled

Trial Details

Trial ID

NCT03343171

Start Date

September 15 2010

End Date

September 1 2025

Last Update

January 31 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

HYKS-instituutti Oy

Helsinki, Finland, FI-00029 HUS

2

Dipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Università di Pisa

Pisa, Italy, 56124

3

Policlinico Tor Vergata

Rome, Italy

4

Glasgow Royal Infirmary

Glasgow, United Kingdom, G4 0SF