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Total Hip Replacement SystemPhase 4COMNCT00820443

Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial

A Phase 4 study testing Ceramic on metal prosthesis in people with Total Hip Replacement System, run by MicroPort Orthopedics Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip when compared to a TRANSCEND® historical control group of patients with primary total hip replacement. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Total Hip Replacement System
What is being tested?
Ceramic on metal prosthesis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
1 siteUnited States
Study dates
Jun 2007to Oct 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be 18 years of age or older at the time of enrollment,
  • Patient is skeletally mature,
  • Evidence of a signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study,
  • Patient agrees to comply with this protocol, including participating in required follow-up visits at the investigational site and completing study questionnaires, (i.e. patient's reasonable driving distance to assure study follow-up and completion)
  • Investigator determines patient is a suitable candidate for primary total hip replacement,
  • Body Mass Index (BMI) of <40,
  • Preoperative Harris Hip Score (HHS) < 70 points as calculated on the Pre-screening Qualification Form and verified by the Sponsor,
  • Have a diagnosis of degenerative joint disease of the hip.

Who cannot join

  • Previous total hip replacement, hemi-arthroplasty, or fusion on the ipsilateral side,
  • Patients with a previous Girdlestone procedure,
  • Patient has a known metal allergy to any component of the investigational device (e.g.cobalt, chromium, titanium or ceramics),
  • Patient has had a total knee arthroplasty of either leg,
  • Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb (based on the Investigator's discretion),
  • Patients with congenital disorder or deformity not adequately addressed by hip replacement or has sufficient anatomic variance or remodeling of the hip joint that may place the patient at risk for mechanical failure or that requires a structural bone graft (based on the Investigator's discretion),
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  • Patients with severe instability or deformity of the ligaments or surrounding soft tissues that would preclude stability of the implant (based on the Investigator's discretion),
  • Patients with Charcot or neuropathic arthropathy, or neuromuscular disease or any other condition that would interfere with patient self-assessment or pain, the function or quality of life required for patient reported outcomes during the study (based on the Investigator's discretion),
  • Patient, male or postmenopausal female, with a history of metabolic bone disease, as defined by the following:
  • Osteoporosis where the patient is currently taking prescription medications that increase bone-mineral density (e.g. Fosamax, Didronel), or
  • Patient was previously diagnosed with a metabolic bone disease (e.g. Paget's disease or osteomalacia), or
  • Patient has any other metabolic bone disease to a degree that the investigator determines that a THR would be contraindicated,
  • Active malignancy,
  • Patient has an active infection (e.g. hepatitis, AIDS, ARC or is HIV positive)- systemic or at the site of intended surgery,
  • Clinical diagnosis of renal insufficiency where renal function is abnormal and incapable of sustaining essential bodily functions. (e.g. as reported by KRONOS lab BUN, Creatinine and estimated glomerular filtration rate (GFR <15 mL/min/1.73 m2)
  • Currently participating in any investigational studies not related to this study's preoperative or postoperative care,
  • Patient has a mental illness or belongs to a vulnerable population (e.g., is a prisoner or a severe drug abuser, or is developmentally disabled) such that his or her ability to provide informed consent or comply with follow-up requirements is compromised,
  • Patient is pregnant or interested in becoming pregnant in the next 2 years, (Due to the required x-rays for the study),
  • Other severe acute or chronic medical condition that may interfere with the interpretation of the study results, in the judgment of the investigator, which would make the patient inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • St. Vincent's Hospital

    Los Angeles, California, 90057

Other trials in United States

About this study

Official title: Ceramic on Metal Total Hip Replacement System IDE: A Non-Randomized, Multi-center, Historically Controlled Safety and Efficacy Study (Protocol Number:06-LJH-002)

The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip when compared to a TRANSCEND® historical control group of patients with primary total hip replacement.

Read the detailed description

This investigational device study is a non-randomized, non-inferiority, multi-center, historically controlled study. The primary objective will be evaluated at the primary endpoint (24 months) by the primary efficacy and safety measures that define patient success. The proportion of patient success will determine whether the primary objective has been met (study success).

The investigational device will be compared to a historical control comprised of patients from the TRANSCEND® Ceramic on Ceramic IDE study. This comparison will be made using all primary and secondary measures. However, only primary measures will be used to determine study success.

Being tested
Ceramic on metal prosthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ceramic on metal prosthesisDevice

    Ceramic femoral head with a metal acetabular component

Study groups in NCT00820443
Study groupRoleWhat they receive
Ceramic on metal prosthesisExperimentalCeramic on metal prosthesis
Receives: Device: Ceramic on metal prosthesis

What is being measured

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

  1. Primary Endpoint/Measures: Success at 24 Months

    The patient success definition is measured at the 24 month interval by the following:

    • Harris Hip Score (HHS) of > 80 • < 2mm radiolucency (width) in any Gruen (stem) or DeLee/Charnley (cup) zone and no more than mild pain.
    • No revision or removal of any part of the device for aseptic reasons prior to or on day 730 following the index surgical procedure.

    A patient must meet all three criteria in the definition to be considered a success. A patient who does not meet all three criteria will be deemed a failure.

    The Harris hip score, is used to measure the outcome of total hip arthroplasty. Eight sections on the HIP are rated by the patient: pain, distance walked, activities, public transportation, support, limp, stairs and sitting. Total scores are out of 100 and grouped as follows: 90 - 100 Excellent,80 - 90 Good,70 - 79 Fair,60 - 69 Poor.< 60 Failed.Any score above 60 is acceptable, although the higher the score, the better the patient's overall adjustment after the surgery

    Measured: 24 Month

Secondary outcomes (4)

  1. The Secondary Measures of the UCLA Functional Assessments

    UCLA: University of California LosAngeles Activity Score

    UCLA score is a validated scoring system for hip replacement outcome, The single item UCLA scale asks patients to rate their activity level from 1 to 10, with 1 defined as "no physical activity" and 10 defined as "regular participation in impact sports". The score is the higher the better.

    Measured: 24 months

  2. WOMAC Raw Total Score

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations (range is 0-96).

    Measured: 24 months

  3. Metal Ion Analysis (Unilateral Only):Serum Cobalt

    Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant.

    Measured: 24 months

  4. Metal Ion Analysis; Unilateral Only; Serum Chromium

    Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant

    Measured: 24 months

Timeline

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

  1. First posted12 Jan 2009 (estimated)
  2. Study startJun 2007
  3. Primary completionJun 2013
  4. Study completionOct 2013

Why it stopped: not move forward with the commercialization of this product based on marketing needs and there is not a known safety issue or concern

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00820443
Sponsor's protocol ID
06LJH002
Acronym
COM
Status last verified
Aug 2015
First submitted
8 Jan 2009
Last updated
30 Sep 2015
Data monitoring committee
No

Publications

  • National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.

    PubMed 11904577

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ceramic on metal prosthesis in people with Total Hip Replacement System, run by MicroPort Orthopedics Inc. at 1 site in United States.

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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary Endpoint/Measures: Success at 24 Months (time frame: 24 Month). 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 NCT00820443, which also lists 1 linked publication.

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 30 Sep 2015.

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