MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads

Not yet recruiting

• Conditions: Hip Fractures; Hip Pain Chronic; Hip Arthritis; Hip Disease; Hip Injuries

• Registration Number: NCT05199870
• Lead Sponsor: Zimmer Biomet

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 and the Endo II Femoral Head 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 and the Endo II Femoral Head 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).

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-22
• Study Start: 2025-08-01
• Primary Completion: 2030-09-03
• Study Completion: 2030-09-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Patient must be 18 years of age or older and skeletally mature

• Patient must have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following:

  • Noninflammatory 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 using other techniques.

Exclusion Criteria

• Any medical diagnosis present at the time of surgery that, at the Investigator's discretion, could compromise the implant's survivability
• Off-label use or not according to the approved instructions for use (IFU) of study devices
• Revision procedures where other treatment or devices have failed
• Uncooperative patient or patient with neurologic disorders who is incapable of following directions
• Patient has a psychiatric illness or

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device safety assessed through the frequency and incidence of revisions, complications, and Adverse Events.	Greater than or equal to 8 years.	The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and Adverse Events. Relation of the events to either implant or instrumentation will be specified.

Secondary Outcome Measures

Name	Time	Method
Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment.	Greater than or equal to 8 years.	The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms. The Patient Assessment is patient completed and a 4-question evaluation.

Trial Locations

Locations (1)

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States