Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04064008
Other study ID # 12-LJH-002M
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 4, 2019
Est. completion date April 2030

Study information

Verified date November 2023
Source MicroPort Orthopedics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Single center, prospective follow-up of previously implanted subjects


Description:

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date April 2030
Est. primary completion date April 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone). 2. Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA. 3. Subject is willing and able to complete required study visits or assessments. 4. Plans to be available through the 10 year postoperative follow-up visit. Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1. the PROFEMUR Z Revision Femoral Stem was implanted in both, 2. all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 4. the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study. Exclusion Criteria: 1. Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol. 2. Subject has a PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 implanted in the enrolled THA. 3. Has or had an overt infection at the time of implantation. 4. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation. 5. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation. 6. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable. 7. Subjects unwilling to sign the Informed Consent document. 8. Subjects with substance abuse issues. 9. Subjects with an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study. 10. Subjects who are incarcerated or have pending incarceration.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PROFEMUR® Z Revision Femoral Stem
Total Hip Total Hip Arthroscopy

Locations

Country Name City State
Poland Samodzielny Publiczny Szpital Kliniczny Klinika Otwock

Sponsors (1)

Lead Sponsor Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Other to characterize total functional scores for subjects, as assessed by EQ-5D-3L scores. EQ-5D-3L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 3 levels: no problems, some problems, and extreme problems. 2-5 years, 5-7 years, and 10 years.
Primary Survivorship of ProFemur Z Stem out to 10 years Kaplan-Meier survivorship at specific intervals out to 10 years follow up 10 years.
Secondary Revision rate of the Profemur Z stem out to 10 years Cummulative revision rate at early (2-5yrs), midterm (5-7 year) and long-term (10 year) follow up. 2-5 years, 5-7 years, and 10 years.
Secondary to characterize total functional scores for subjects, as assessed by Oxford Hip Scores The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'. 2-5 years, 5-7 years, and 10 years.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02314702 - Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
Completed NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03271151 - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty Phase 4
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT01256216 - Signature Versus Computer Assisted Surgery Study N/A
Completed NCT03337243 - Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis N/A
Active, not recruiting NCT03294408 - Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model N/A
Withdrawn NCT02668211 - Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components N/A
Active, not recruiting NCT02239783 - Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems
Terminated NCT00698347 - A Clinical Investigation of the M2a-Magnumâ„¢ Hip System N/A
Completed NCT00223353 - Quantitative Gait Analysis for Clinical Decision Making N/A
Recruiting NCT04037735 - RSA-RCT: Attune S+ TKA Versus Sigma TKA N/A
Terminated NCT03575975 - 3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
Completed NCT03894514 - Multi-variable Prediction Model of Total Knee Replacement Outcome
Completed NCT02865447 - Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis
Enrolling by invitation NCT03576573 - Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
Completed NCT02967874 - Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment Phase 1/Phase 2
Completed NCT02390336 - Mobilization With Movement in Patients With Osteoarthritis of the Hip N/A
Terminated NCT03293719 - Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic
Active, not recruiting NCT02823834 - PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components