Maxera Large Cups - Canada

NCT04348968 | Terminated

• 1 other identifier: MDRG2017-89MS-15H
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is monocentric, retrospective and prospective, non-controlled, consecutive series Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Largest Zimmer® Maxera™ Cup (Implants and Instrumentation)

Conditions

Degenerative Joint Disease of Hip; Osteoarthritis, Hip; Avascular Necrosis of Hip; Post-Traumatic Osteoarthritis of Hip; Congenital Dysplasia of the Hip; Joint Diseases; Rheumatoid Arthritis of Hip

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method

  10 years post-surgery

Secondary Outcomes (4)

• Pain and functional performance based on the Harris Hip Score

  10 years post-surgery

• Subject quality-of-life determined by the EQ-5D (EuroQoI) score

  10 years post-surgery

• X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc

  10 years post-surgery

• Safety based on eventual complications occurred including dislocations and revisions/removals

  10 years post-surgery

Study Arms (1)

Patient who received a Maxera Cup of large diameter

Patient received a Maxera Cup with an outer diameter of 64 mm or 66 mm between Nov 2011 and Feb 2018.

Device: Total hip arthroplasty

Interventions

Total hip arthroplasty DEVICE

The THA surgical procedure involves replacing the head of the femur and acetabulum or socket with an artificial prosthesis. This system is composed of a femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral stem, and an acetabular component or shell that replaces the acetabulum. In this study, the acetabular component is the Zimmer Maxera Cup, which is a monoblock construct consisting of a pre-assembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation. The Maxera Cup is intended for single use only and is designed for reconstruction of the hip joint for conditions described in the inclusion and exclusion section of this protocol.

Also known as: Total hip replacement

Patient who received a Maxera Cup of large diameter

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigator provided a list of 32 patients operated consecutively between Nov 2011 and Feb 2018. These patients received the Maxera Cup of outer diameter 64 or 66 mm. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant. The investigator will contact these patients to propose study enrollment until he can ensure 20 consecutive THA procedures. He will get their informed consent and retrospectively collect the preop, surgery, immed postop, and 1 year data These 20 patients will be followed-up in the frame of the standard clinicla routine and clinical data will be prospectively collected by the investigator at the 5, 7 and 10-year follow-up visits

You may qualify if:

• Patient received a Maxera Cup with an outer diameter of 64 mm or 66 mm.
• The Zimmer Maxera Cup is indicated for non-cemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of non-inflammatory degenerative joint disease (NIDJD) including but not limited to osteoarthritis, avascular necrosis, post-traumatic arthritis, congenital hip dysplasia, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate.

You may not qualify if:

• Active, old, or remote infection of the hip.
• Osteoradionecrosis.
• Local bone tumors and/or cysts.
• Patients with poor bone quality, where there is inadequate bone to support the implant(s).
• Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
• Allergy to the implanted material.
• Patient's physical conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, e.g. previous surgery, insufficient quality or quantity of bone resulting from conditions such as cancer or congenital dislocation, metabolic bone disease of the upper femur or pelvis, femoral osteotomy revision, girdle stone revision, osteoporosis, osteomyelitis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures, joint neuropathy) or other conditions that may lead to inadequate skeletal fixation
• Do not use ceramic femoral heads which are not BIOLOX delta or BIOLOX OPTION with Maxera components.
• Use of this device when a less invasive procedure would be sufficient.
• Skeletal immaturity.
• Any nerve or muscle disease that may have a negative effect on gait or weight bearing
• Loss of abductor musculature in the affected limb.
• Poor skin coverage around the hip joint.
• Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, QC H1T 2M4, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Hip Dislocation, Congenital; Joint Diseases

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Paola Vivoda

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: March 1, 2021
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-03

Locations

CA (1)