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OsteoarthritisNCT03343171

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

An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 6 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Read more about this study

Who is it for?
Ages 21 to 75 years
How many people
203 participants
Where
6 sitesin 3 countries
Study dates
15 Sep 2010to Sep 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients, suffering from severe hip pain and disability requiring total hip arthroplasty, who meet the inclusion/exclusion criteria and who receives the Continuum™ Ceramic Bearing System.

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

United Kingdom3 sites

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF

  • Nuffield Department of Orthopaedics, University of Oxford

    Oxford, OX3 7LD

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Italy2 sites

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

    Pisa, 56124

  • Policlinico Tor Vergata

    Rome

Other trials in Italy

Finland1 site

  • HYKS-instituutti Oy

    Helsinki, FI-00029 HUS

Other trials in Finland

About this study

Official title: Continuum™ Ceramic Bearing System in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

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 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 efficacy of the Continuum Ceramic-on-Ceramic Bearing System.

Read the 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 Acetabular Shell, a modular BIOLOX delta Taper liner, and a modular BIOLOX delta femoral head. The characteristics of this THA system may allow for reduction in wear and osteolysis as compared to other approved and marketed THA systems and thus increase the expected implant life. The study design will be a prospective, multicenter, non-comparative post-market study, involving orthopedic surgeons skilled in hip arthroplasty procedures. A total of 200 patients will be enrolled into the study distributed between 6 study centres. This number of clinical centers will permit assessment of consistency among a multitude of investigators. Follow-up visits will. be performed at 6 weeks, 6 months, 1,2, 3, 5; 7 and 10 years post-operatively. All potential study subjects will be required to participate in the Informed Consent Process.

The safety and performance of the Implant System will be assessed as following: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and Performance will be determined by comparing the overall pain and functional performances, survivorship, subject quality-of-life and radiographic parameters of study subjects who received the Continuum Ceramic Bearing System.

Keywords
total hip arthroplasty
Medical subject headings
Osteoarthritis, Osteonecrosis, Arthritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety will be evaluated by adverse events reporting.

    Safety will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE)

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start15 Sep 2010
  3. Primary completionFeb 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03343171
Sponsor's protocol ID
09-H02
Status last verified
Jan 2025
First submitted
10 Nov 2017
Last updated
31 Jan 2025
Results posted
No
FDA-regulated drug
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom, Italy, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety will be evaluated by adverse events reporting. (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03343171.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.

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