MDR - Longevity IT Oblique and Offset Liners

Osteoarthritis Clinical Trial

Official title:

PMCF Study to Provide Safety, Performance, and Clinical Benefits Data of the Longevity IT Oblique and Offset Liners in Primary and Revision Total Hip Arthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05980234
• Other study ID #: MDRG2017-89MS-107H
• Status: Enrolling by invitation
• Start date: August 30, 2023
• Est. completion date: August 1, 2035

Study information

• Verified date: September 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 Longevity IT Oblique and Offset liners when used for primary or revision total hip arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.

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 Longevity IT Oblique and Offset liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 1, 3, 5, 7, and 10 years*. The subject devices have been on the market since 2010 but have insufficient data to support 10 years of clinical history. A prospective aspect to the study will be utilized to collect long-term data.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 104
• Est. completion date: August 1, 2035
• Est. primary completion date: August 1, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Study devices must have been implanted following the appropriate surgical technique and IFU

• Patient must be 18 years of age or older

• Patient must be willing and able to sign or verbally consent using the IRB approved informed consent

• Patient must have undergone primary or revision hip arthroplasty with the Longevity IT Oblique and/or Offset liners according to a cleared indication, which includes the following:

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital, epiphysis, fused hip, fracture of the pelvis, and diastrophic variant

• Revision where other devices or treatments have failed

• Patient must have reached full skeletal maturity

Exclusion Criteria:

• Off-label use of study devices

• Osteoradionecrosis

• Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation

• Systemic or local infection

• Uncooperative patient or patient with neurologic disorders who is incapable of following directions

• 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

Related Conditions & MeSH terms

• Avascular Necrosis
• Joint Diseases
• Necrosis
• Non-inflammatory Degenerative Joint Disease (NIDJD)
• Osteoarthritis
• Slipped Capital Femoral Epiphyses
• Traumatic Arthritis

Intervention

Device:
• Total Hip Arthroplasty with Longevity IT Oblique Liners
Primary or Revision Total Hip Arthroplasty using the Longevity IT Oblique liners according to the approved indications and compatible device.
• Total Hip Arthroplasty with Longevity IT Offset Liners
Primary or Revision Total Hip Arthroplasty using the Longevity IT Offset liners according to the approved indications and compatible device.

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent Adverse Events (safety)	This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events with particular focus on those that may be related to the study device.	10 years
Secondary	Pain and Functional Performance - Oxford Hip Score	"The Oxford Hip Score is patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement surgery.; Grading the Oxford Hip Score 0 to 19-May indicate severe hip arthritis... 20 to 29-May indicate moderate to severe hip arthritis... 30 to 39-May indicate mild to moderate hip arthritis... 40 to 48-May indicate satisfactory joint function..." Oxford Hip Score. (n.d.) Segen's Medical Dictionary. (2011). Retrieved August 19 2022 from https://medical-dictionary.thefreedictionary.com/Oxford+Hip+Score	10 years
Secondary	Performance and Clinical Benefits - Harris Hip Score	Patient Assessment: reported Harris Hip Score (if available); Harris Hip Score: The HHS is divided into three sections. The first section questions is about pain and its impact, which are answered by the patient or client. The second and third sections require the physiotherapist to assess the patient or client's hip joint and function.; The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.	10 years
Secondary	Performance and Clinical Benefits - Activity Level	Patient Assessment: activity level; Records patient's activity level on a 10-point scale from 'wholly inactive' to 'regularly particpates in impact sports.	10 years