Osteoarthritis, Hip Clinical Trial
— Maxera CanadaOfficial title:
Retrospective and Prospective Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Maxera™ Cup (Implants and Instrumentation)
Verified date | March 2021 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
Status | Terminated |
Enrollment | 20 |
Est. completion date | March 25, 2021 |
Est. primary completion date | March 25, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Hôpital Maisonneuve-Rosemont | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method | 10 years post-surgery | ||
Secondary | Pain and functional performance based on the Harris Hip Score | The score is given from 0 to 100 with Excellent: 90 - 100, Good: 80 - 89, Fair: 70 - 79, and Poor: < 70 | 10 years post-surgery | |
Secondary | Subject quality-of-life determined by the EQ-5D (EuroQoI) score | The lowest score (0) corresponds to "the worst health the patient can imagine", and the highest rate (100) corresponds to "the best health he can imagine". | 10 years post-surgery | |
Secondary | X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc | 10 years post-surgery | ||
Secondary | Safety based on eventual complications occurred including dislocations and revisions/removals | 10 years post-surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05773261 -
Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
|
N/A | |
Recruiting |
NCT05223777 -
KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)
|
N/A | |
Recruiting |
NCT04731077 -
Avenir Complete Post-Market Clinical Follow-Up Study
|
N/A | |
Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT06162195 -
The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
|
N/A | |
Withdrawn |
NCT02743208 -
Evaluation of a Short Femoral Stem in Total Hip Arthroplasty
|
N/A | |
Completed |
NCT02944448 -
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
|
Phase 2 | |
Active, not recruiting |
NCT02229279 -
Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures
|
N/A | |
Active, not recruiting |
NCT02851992 -
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
|
N/A | |
Completed |
NCT01700933 -
Dose-response: Exercise Therapy on Hip Osteoarthritis
|
N/A | |
Completed |
NCT01618708 -
A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip
|
N/A | |
Completed |
NCT01214954 -
Early Rehabilitation After Total Hip Replacement
|
N/A | |
Active, not recruiting |
NCT00294424 -
Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements
|
N/A | |
Terminated |
NCT00588861 -
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
|
N/A | |
Withdrawn |
NCT05054595 -
Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
|
N/A | |
Terminated |
NCT00973141 -
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
|
Phase 2 | |
Recruiting |
NCT05014113 -
H-28 DELTA ST-C and Minima Retrospective Study.
|
||
Completed |
NCT01066936 -
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
|
||
Recruiting |
NCT06185036 -
Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint
|