Clinical trial NCT05199870: MDR - PMCF Study for RingLoc Bipolar Acetabular Cup
Official title: Post-Market Clinical Follow-Up Study to Provide Safety, Performance and Clinical Benefits Data of the RingLoc Bipolar Acetabular Cup (Implants and Instrumentation) in Hip Hemiarthroplasty - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hip Arthritis
Hip Disease
Hip Fractures
Hip Injuries
Hip Pain Chronic
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A consecutive series of patients implanted with the RingLoc Bipolar acetabular cup.

Brief summary: The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup when used for hip hemiarthroplasty (implants and instrumentation).

Detailed description: The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup when used for hip hemiarthroplasty (implants and instrumentation).

The primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to implant, instrumentation and/or procedure should be specified.

The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).

Eligibility criteria: Inclusion Criteria:

* Patient must be 18 years of age or older and skeletally mature
* Patient must be willing and able to sign IRB approved informed consent
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Revision procedures where other treatment or devices have failed

Exclusion Criteria:

* Off-label use
* Uncooperative patient or patient with neurological disorders who are incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, or neuromuscular disease
* Infection
* Sepsis
* Osteomyelitis
* Patient is known to be pregnant or nursing
* Patient is a prisoner
* Patient is a known alcohol or drug abuser
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
* Patient is unwilling to sign an informed consent

Primary outcomes:
measure: Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.
timeFrame: Greater than or equal to 8 years.
Secondary outcomes:
measure: Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment.
timeFrame: Greater than or equal to 8 years.
Other outcomes:
Locations:
Study officials:
affiliation: Zimmer Biomet
name: Jarrod Hunnicutt
role: STUDY_DIRECTOR
References: