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

NCT03672370 | Terminated Results

• 1 other identifier: CME2014-03H.1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Avascular Necrosis; Osteoarthritis; Inflammatory Arthritis; Posttraumatic Arthritis

Keywords

Total hip arthroplasty; Medical device; Performance; Safety; Hip prosthesis

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  4 years

Secondary Outcomes (2)

• Oxford Hip Score

  3 years

• EQ-5D

  3 years

Study Arms (1)

Alloclassic® Variall® Cup

Subjects who received the Alloclassic® Variall® Cup Ceramic Bearing System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Herz-Jesu Krankenhaus

Vienna, 1030, Austria

Location

Orthopädisches Spital Speising GmbH

Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Osteonecrosis; Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Rheumatic Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Clinical Project Lead, Sandra Rosser
• Organization: Zimmer Biomet

sandra.rosser@zimmerbiomet.com

+41 (0)58 854 84 09

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: March 24, 2015
• Primary Completion: May 14, 2019
• Study Completion: May 1, 2020
• Last Updated: January 14, 2021
• Results First Posted: January 14, 2021

Record last verified: 2020-11

Locations

AU (2)