Avascular NecrosisNCT03672370

PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty

An observational study of Avascular Necrosis and Osteoarthritis, run by Zimmer Biomet at 2 sites in Austria.

Terminated

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

Trial summary

The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis
How many people: 100 participants
Where: 2 sitesAustria
Study dates: 24 Mar 2015to 1 May 2020
Phase: Observational
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients in need of a primary Total Hip Arthroplasty which receive the Alloclassic® Variall® Cup in combination with a BIOLOX ® delta Taper Liner and a BIOLOX ® delta Femoral Head

Who may be able to join

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
Post-traumatic arthritis

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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.

Show all 17Show fewer

The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
The patient has a known history of 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 is not having any other investigational drug or device simultaneously.
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. clinical relevant 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 Inldex (BMI) > 40.

Trial locations and contacts

2 sites in 1 country.

Austria2 sites

Herz-Jesu Krankenhaus
Vienna, 1030
Orthopädisches Spital Speising GmbH
Vienna, 1130

Other trials in Austria

About this study

Official title: Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip Arthroplasty A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study.

Read the detailed description

The objectives of this study are to obtain survival and outcomes data on the Alloclassic® Variall® Cup in combination with the BIOLOX® delta Taper Liner and a BIOLOX® delta Femoral Head used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records.

Two sites are involved in this study, enrolling a total of 100 patients for the study. All subjects were required to participate in the Informed Consent Process.

Conditions: Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Posttraumatic Arthritis
Keywords: Total hip arthroplasty, Medical device, Performance, Safety, Hip prosthesis
Medical subject headings: Osteonecrosis, Osteoarthritis, Arthritis

What participants receive

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

Study groups in NCT03672370
Study group	Role	What they receive
Alloclassic® Variall® Cup		Subjects who received the Alloclassic® Variall® Cup Ceramic Bearing System

What is being measured

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

Clinical Success Will be Based on the Harris Hip Scoring System
The Harris Hip Score (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 points and a maximum of 100 points.
Clinical success will be defined as a modified Harris Hip score of > 80 that included a rating of 'mild', or 'no pain'; a failure will be defined as a modified Harris Hip score < 80.
Measured: 3 years
Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate
Endpoint revision of any investigational device for any reason attributable to any investigational device
Measured: 4 years

Secondary outcomes (2)

Oxford Hip Score
The purpose of the Oxford Hip Score (OHS) is to assess the outcome after total hip arthroplasty by measuring cases' perceptions in adjunction to surgery. The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc.
The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score
Measured: 3 years
EQ-5D
The EQ-5D questionnaire comprises two parts. For the first part, respondents are asked to tick boxes to indicate the level of problem on each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In total, there are three levels per dimension (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Responses are coded as single-digit numbers expressing the severity level selected in each dimension. The digits for the five dimensions are combined in a 5-digit code.
The second part of the questionnaire is the EQ Visual Analogue Scale. This captures the respondent's overall assessment of their health from 0 (worst health imaginable) to 100 (best health imaginable).
The results from both parts are indexed, weightened and pulled together. The final score lies between 1 for full health and 0 for death. Values less than 0 are possible considered to be worse than death.
Measured: 3 years

Timeline

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

24 Mar 20151 May 2020

First posted14 Sep 2018
Study start24 Mar 2015
Primary completion14 May 2019
Study completion1 May 2020

Why it stopped: Study terminated as CE marks of the devices used have not been renewed.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Avascular NecrosisStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03672370
Sponsor's protocol ID: CME2014-03H.1
Status last verified: Nov 2020
First submitted: 13 Sep 2018
Last updated: 14 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Active, not recruiting
Avenir Complete Post-Market Clinical Follow-Up Study
Osteoarthritis, Hip, Avascular Necrosis of Hip
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis

All Avascular Necrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip Arthroplasty A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
ClinicalTrials.gov ID: NCT03672370
Acronym / sponsor ID: CME2014-03H.1
Conditions: Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Posttraumatic Arthritis
Keywords: Total hip arthroplasty, Medical device, Performance, Safety, Hip prosthesis
Study type: Observational
Recruitment status: TerminatedReason stopped: Study terminated as CE marks of the devices used have not been renewed.
Enrolment: 100 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 24 Mar 2015 (actual)
Primary completion: 14 May 2019 (actual)
Study completion: 1 May 2020 (actual)
First posted: 14 Sep 2018 (actual)
Results: Posted 14 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study.

Detailed description

Two sites are involved in this study, enrolling a total of 100 patients for the study. All subjects were required to participate in the Informed Consent Process.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Alloclassic® Variall® Cup	–	–Subjects who received the Alloclassic® Variall® Cup Ceramic Bearing System

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients in need of a primary Total Hip Arthroplasty which receive the Alloclassic® Variall® Cup in combination with a BIOLOX ® delta Taper Liner and a BIOLOX ® delta Femoral Head

Key inclusion criteria (12 listed)

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:
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.

Key exclusion criteria (17 listed)

The patient is:
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 neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
The patient has a known history of systemic disease that could affect his/her safety or the study outcome.
The patient is known to be pregnant.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Clinical Success Will be Based on the Harris Hip Scoring System
Time frame: 3 years
The Harris Hip Score (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 points and a maximum of 100 points. Clinical success will be defined as a modified Harris Hip score of > 80 that included a rating of 'mild', or 'no pain'; a failure will be defined as a modified Harris Hip score < 80.
Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate
Time frame: 4 years
Endpoint revision of any investigational device for any reason attributable to any investigational device

2 secondary outcomes

Oxford Hip Score
Time frame: 3 years
EQ-5D
Time frame: 3 years

Results and safety

Results posted to the registry on 14 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alloclassic Variall Cup	89	42

Primary outcome: Clinical Success Will be Based on the Harris Hip Scoring System

Time frame: 3 years. Mean (Standard Deviation). Unit: score on a scale

Measure	Alloclassic Variall Cup n = 42
Value	92.6 (8.9)

Primary outcome: Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate

Time frame: 4 years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Alloclassic Variall Cup n = 89
Value	98.63 (90.67 to 99.81)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alloclassic Variall Cup	7 of 89 (7.9%)	2 of 89 (2.2%)	1 of 89

Limitations and caveats (from the sponsor): Early termination of the study, many withdrawals of patients as they felt good and did not see the necessarity to come back to the follow-up visits.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Avascular Necrosis

Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Active, not recruiting
Avenir Complete Post-Market Clinical Follow-Up Study
Osteoarthritis, Hip, Avascular Necrosis of Hip
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hassan Achakri study director

Zimmer Biomet

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Avascular Necrosis and Osteoarthritis, run by Zimmer Biomet at 2 sites in Austria.

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 12 inclusion and 17 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. 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?

Yes. Results are posted in the registry (first posted 14 Jan 2021). 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?

Clinical Success Will be Based on the Harris Hip Scoring System (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT03672370.

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 14 Jan 2021.