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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 February 2024
• Main ID: NCT03343171
• Date of registration: 10/11/2017
• Prospective Registration: No
• Primary sponsor: Zimmer Biomet
• Public title: Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study
• Scientific title: Continuum™ Ceramic Bearing System in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
• Date of first enrolment: September 15, 2010
• Target sample size: 203
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03343171
• Study type: Observational

Countries of recruitment

Finland, Italy, United Kingdom

Contacts

• Name: Hassan Achakri
• Affiliation: Zimmer Biomet

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 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 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



Age minimum: 21 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis

Post-traumatic Arthritis

Inflammatory Arthritis

Avascular Necrosis

Primary Outcome(s)

Safety will be evaluated by adverse events reporting. [Time Frame: 10 years]

Secondary ID(s)

09-H02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors