Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01484002
Other study ID # AORI2011-0101
Secondary ID MGH Agreement No
Status Enrolling by invitation
Phase N/A
First received November 28, 2011
Last updated January 23, 2017
Start date December 2011
Est. completion date December 2017

Study information

Verified date January 2017
Source Anderson Orthopaedic Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This retrospective study will investigate the changes that occur in ultrahigh molecular weight polyethylene (UHMWPE) implants that have been retrieved from joint replacement patients. Analysis techniques will include Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimeter (DSC) and crosslink density measurements. Crosslink density measurements will be evaluated as a function of distance away from the articular surface and the rim of the implant. Gel and hydroperoxide contents will also be evaluated. The objective is to characterize the in vivo and ex vivo changes that occur with cross-linked and conventional polyethylene bearings sterilized by methods that do not involve radiation. The investigators hypothesize that polyethylene absorbs lipids in vivo but experiences negligible oxidation or reductions in polymer crosslinking until it is explanted and stored at room temperature with access to ambient air.


Description:

For many years, gamma-irradiation in air was a common method for the terminal sterilization of ultrahigh molecular weight polyethylene (UHMWPE) materials used for joint replacement. A serendipitous byproduct of sterilization with gamma-irradiation was polymer crosslinking that tended to improve the wear performance of the polyethylene. During the 1990s, however, the orthopaedic community became aware that gamma-irradiation created free radicals within polyethylene, rendering the material susceptible to oxidative degradation. In view of this potentially deleterious effect, terminal sterilization methods using chemical surface treatments were developed to avoid free radical formation. To induce polyethylene crosslinking without residual free radicals, manufacturers also developed methods to crosslink the polyethylene followed by heat treatments to eliminate free radicals. These crosslinked materials were introduce during the latter part of the 1990s and clinical outcome studies among hip replacement patients have demonstrated substantially reduced wear at early follow-up intervals based on radiographic measurements. However, the long-term performance of crosslinked polyethylene is unknown and some investigators have expressed concerns related to in vivo degradation. Additionally, some crosslinked UHMWPE components have shown high levels of oxidation and chain scission after removal from patients and storage in air. Among these implants, it is unknown whether the oxidation and chain scission occurred during implantation or after the polyethylene was removed from the patient.

This study will characterize the material properties of polyethylene liners retrieved from hip replacement patients. The study population will include crosslinked and conventional UHMWPE liners that were terminally sterilized without the use of radiation. To quantify the potential effects of different storage methods, liners that were vacuum packed and frozen after retrieval and others that were stored at room temperature with access to ambient light and air following explantation will be included in the study population. Analysis techniques will include Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimeter (DSC) and crosslink density measurements. Crosslink density measurements will be evaluated as a function of distance away from the articular surface and the rim of the implant. Gel and hydroperoxide contents will also be evaluated. The goal of the analysis is to better understand the changes in polyethylene material properties that occur in vivo and ex vivo.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Retrieved total hip arthroplasty liners maintained by the Anderson Orthopaedic Research Institute

- Crosslinked or conventional liners terminally sterilized without gamma-irradiation

Exclusion Criteria:

- Liners terminally sterilized with gamma-irradiation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Total hip arthroplasty
Replacement of a patient's native hip with an artificial implant featuring a metal-on-polyethylene articulation

Locations

Country Name City State
United States Anderson Orthopaedic Research Institute Alexandria Virginia
United States Orthopaedic Biomechanics and Biomaterials Laboratory at Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Anderson Orthopaedic Research Institute DePuy Orthopaedics, Orthopaedic Biomechanics and Biomaterials Laboratory at Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bargmann LS, Bargmann BC, Collier JP, Currier BH, Mayor MB. Current sterilization and packaging methods for polyethylene. Clin Orthop Relat Res. 1999 Dec;(369):49-58. — View Citation

Currier BH, Currier JH, Mayor MB, Lyford KA, Collier JP, Van Citters DW. Evaluation of oxidation and fatigue damage of retrieved crossfire polyethylene acetabular cups. J Bone Joint Surg Am. 2007 Sep;89(9):2023-9. — View Citation

Currier BH, Van Citters DW, Currier JH, Collier JP. In vivo oxidation in remelted highly cross-linked retrievals. J Bone Joint Surg Am. 2010 Oct 20;92(14):2409-18. doi: 10.2106/JBJS.I.01006. — View Citation

Engh CA Jr, Stepniewski AS, Ginn SD, Beykirch SE, Sychterz-Terefenko CJ, Hopper RH Jr, Engh CA. A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non-cross-linked Enduron polyethylene liners. J Arthroplasty. 2006 Sep;21(6 Suppl 2):17-25. — View Citation

Malchau H, Bragdon CR, Muratoglu OK. The stepwise introduction of innovation into orthopedic surgery: the next level of dilemmas. J Arthroplasty. 2011 Sep;26(6):825-31. doi: 10.1016/j.arth.2010.08.007. — View Citation

Muratoglu OK, Wannomae KK, Rowell SL, Micheli BR, Malchau H. Ex vivo stability loss of irradiated and melted ultra-high molecular weight polyethylene. J Bone Joint Surg Am. 2010 Dec 1;92(17):2809-16. doi: 10.2106/JBJS.I.01017. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Oxidation levels Polyethylene oxidation levels will be quantified as a function of depth away from the articular and rim surfaces using Fourier Transform Infrared Spectroscopy (FTIR). Pre and post-hexane and nitric oxide (NO) exposed post-hexane thin sections will be analyzed. At an average of 5 years in vivo
Secondary Absorbed lipids Absorbed lipids will be evaluated by determining the level of carbonyls before and after hexane extraction using Fourier Transform Infrared Spectroscopy (FTIR). At an average of 5 years in vivo
Secondary Crosslink density Crosslink density will be evaluated using the gravimetric method on thin sections (~300µm) cut co-planar to the articular surfaces. At an average of 5 years in vivo
Secondary Differential Scanning Calorimeter (DSC) Differential Scanning Calorimeter (DSC) will be used to determine the 1st and 2nd heats, and 1st cool crystallinity, peak melting/crystallization points. At an average of 5 years in vivo
Secondary Hydroperoxides Hydroperoxides will be evaluated with FTIR by NO treatment after hexane extraction. At an average of 5 years in vivo
Secondary Vinyl end-groups Vinyl end-groups will be evaluated with FTIR after hexane extraction to quantify chain scission. At an average of 5 years in vivo
Secondary Trans vinylene (TVI) unsaturations Trans vinylene (TVI) unsaturations will be evaluated with FTIR after hexane extraction to determine radiation history and dose. At an average of 5 years in vivo
Secondary Crystallinity Infra-red crystallinity will be evaluated with FTIR after hexane extraction. At an average of 5 years in vivo
Secondary Gel content To quantify the extent of chain scission, gel content will be evaluated by measuring the non-extractable portion of the molecules using thin sections cut co-planar to the articular surfaces with a microtome and extracting the polyethylene chains from these sections in hot xylene. At an average of 5 years in vivo
See also
  Status Clinical Trial Phase
Completed NCT04657926 - A Trial of APPA in the Treatment of Knee Osteoarthritis Phase 2
Completed NCT02536833 - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects Phase 2
Completed NCT03014037 - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration N/A
Recruiting NCT05937542 - A Qualitative Investigation of CLEAT Participants
Completed NCT03644615 - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT03850665 - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach N/A
Completed NCT02826902 - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial N/A
Completed NCT04402502 - Dynamic 4DCT to Examine Wrist Carpal Mechanics N/A
Completed NCT02923700 - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial Phase 4
Completed NCT04564053 - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants Phase 1
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT05036174 - Diphenhydramine Ointment for Knee Osteoarthritis N/A
Recruiting NCT02912429 - Onlay vs. Inlay Patellofemoral Arthroplasty N/A
Recruiting NCT02666443 - Low Dose Dexamethasone in Supraclavicular Blocks N/A
Active, not recruiting NCT02723929 - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Terminated NCT02820766 - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting N/A
Withdrawn NCT02921594 - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties N/A