Laboratory for Retrieval Research and Reprocessing of Medical Devices
Current Research

 

   Medical Device Performance
  • Analyze retrieved implants, devices
  • Joint replacements: Preclinical testing, simulations
  • Bearing surfaces, bone-biomaterial interface

Innovation for Reprocessing & Reuse

  • Medical device designs: Optimizing for reprocessing
  • Reprocessing protocols: Verification, validation
  • Reusable technology for low-resource settings

Translational Orthopaedic Research

  • Implant registries, post-marketing surveillance
  • Musculoskeletal biomechanics, functional assessments
  • Novel surgical instruments, operative techniques
OrthoWatch

OrthoWatch is a post-marketing surveillance program integrating performance evaluations of joint prostheses with clinical outcomes and implant retrieval analysis.

Once a joint prosthesis has been removed from a patient, it is sent to our lab where it is catalogued and cleaned.  Our constantly expanding data base of retrieved devices combined with a detailed outcome registry affords us the ability to complete post-marketing surveillance.

  GreenMD

GreenMD is an engineering research and training program focused on optimizing medical device designs for reprocessing and reuse and promoting medical device sustainability.

Reprocessing involves cleaning and sterilizing medical devices for reuse during sequential treatments on multiple patients. It helps healthcare providers enhance patient care by controlling supply costs and maintaining safety and quality control. Under the supervision of the Food & Drug Administration, Clemson University and RE-MED are creating a one of a kind training program in this field.

Previous Research

Medical Device Reprocessing
  1. Danesi V, Cristofolini L, Stea S, Traina F, Beraudi A, Tersi L, Harman M, Viceconti M: Re-use of explanted osteosynthesis devices:  A reliable and inexpensive reprocessing protocol.  Injury, 42(10): 1101-1106, 2011.
Shoulder Arthoplasty
  1. Virani NA, Harman MK, Li K, Levy J, Frankle MA, Pupello DR:  In vitro and finite element analysis of glenoid bone/baseplate interaction in the reverse shoulder design.  Journal of Shoulder and Elbow Surgery, 17(3):509-521, 2008.
  2. Harman M; Frankle M; Vasey B; Banks S:  Initial glenoid component fixation in “reverse” total shoulder arthroplasty:  A biomechanical evaluation.  Journal of Shoulder and Elbow Surgery, 14(1S):134-39, 2005.
Hip Arthoplasty
  1. Harman MK, Baleani M, Juda K, Viceconti M: Repeatable procedure for evaluating taper damage on femoral stems with modular necks.  Journal of Biomedical Materials Research (Part B), 99(2):431-439, 2011.
  2. Tanino H, Ito H, Banks SA, Harman MK, Matsuno T:  Deep polyethylene liner for treatment of recurrent dislocation.  Hip International, 20(2):269-272, 2010.
  3. Tanino H, Banks SA, Ito H, Harman MK, Matsuno T, Hodge WA:  An in vivo model for intraoperative assessment of impingement and dislocation in total hip arthroplasty.  Journal of Arthroplasty, 23(5):714-720, 2008.
  4. Tanino H, Harman MK, Banks SA, Hodge WA:  Association between dislocation, impingement and articular geometry in retrieved acetabular polyethylene cups.  Journal of Orthopaedic Research, 25(11):1401-1407, 2007.
  5. Harman MK, Banks SA, Hodge WA: Closed reduction of constrained total hip arthroplasty:  In vitro and clinical evaluation.  Clinical Orthopaedics and Related Research, 414:121-128, 2003.
  6. Harman MK, Banks SA, Hodge WA: Wear analysis of a retrieved hip implant with titanium nitride coating. Journal of Arthroplasty, 12(8):938-945, 1997.
  7. Harman MK, Toni A, Cristofolini L, Viceconti M: Initial stability of uncemented hip stems: An in-vitro protocol to measure torsional interface motion. Medical Engineering and Physics, 17(3):163-171, 1995.
Total & Unicondylar Knee Arthoplasty
  1. Lützner J, Günther KP, Kirschner S, Harman MK:  Patients with no functional improvement after TKA show different kinematics.  Int Orthop, accepted and in press, 2012.
  2. Harman M, Cristofolini L, Erani P, Stea S, Viceconti M. A pictographic atlas for classifying damage modes on polyethylene bearings.  Journal of Materials Science: Materials in Medicine, 22:1137-1146, 2011.
  3. Harman MK, Schmitt S, Rössing S, Banks SA, Scharf HP, Viceconti M, Hodge WA:  Polyethylene damage patterns and deformation in unicondylar knee replacement corresponding to progressive changes in component alignment and fixation.  Clinical Biomechanics, 25(6):570-575, 2010. 
  4. Harman MK, Banks SA, Hodge WA:  Backside damage corresponding to articular damage in retrieved tibial polyethylene inserts.  Clinical Orthopaedics and Related Research, 458:137-44, 2007.
  5. Harman MK, Banks SA, Hodge WA:  Joint replacement design guided by clinical retrievals.  Journal of Biomechanics, 39(Suppl. 1):S120, 2006.
  6. Banks SA, Harman MK, Hodge WA:  Mechanism of anterior impingement damage in total knee arthroplasty.  Journal of Bone and Joint Surgery, 84-A(supplement 2):37-42, 2002. 
  7. Harman MK, Banks SA, Hodge WA: Polyethylene damage and knee kinematics after total knee arthroplasty.  Clinical Orthopaedics and Related Research, 392:383-393, 2001.
Knee Arthoplasty- Joint Mechanics and Computer Simulation
  1. Harman MK, Banks SA, Fregly BJ, Sawyer WG, Hodge WA: Biomechanical mechanisms for damage:  Retrieval analysis and computational wear predictions in total knee replacements.  Journal of Mechanics in Medicine and Biology, 5(3):469-75, 2005.
  2. Fregly BJ, Sawyer WG, Harman MK, Banks SA: Computational wear prediction of a total knee replacement from in vivo kinematics.  Journal of Biomechanics, 38:305-314, 2005.
  3. Banks SA, Bellemans J, Harman MK, Hodge WA: Making sense of knee arthroplasty kinematics: News you can use.  Journal of Bone and Joint Surgery, 85-A(Suppl 4):64-72, 2003.
  4. Banks SA, Bellemans J, Nozaki H, Whiteside LA, Harman MK, Hodge WA: Knee motions during maximum flexion in fixed and mobile-bearing arthroplasties. Clinical Orthopaedics and Related Research, 410:131-138, 2003.
Knee Arthoplasty- Wear Simulation
  1. Spinelli M, Affatato S, Harman MK, DesJardins JD: Bi-unicondylar knee prosthesis functional assessment utilizing force-control wear testing. Proc. IMechE, Part H: Journal of Engineering in Medicine, 224(7), 813-821, 2010.
  2. Harman M, Affatato S, Spinelli M, Zavalloni M, Stea S, Toni A. Polyethylene insert damage in unicondylar knee replacement: A comparison of in vivo function and in vitro simulation. Proc. IMechE, Part H: Journal of Engineering in Medicine, 224(7), 823-830, 2010.
  3. Harman MK, DesJardins JD, Benson LC, Banks SA, LaBerge M, Hodge WA:  Comparison of polyethylene tibial insert damage from in vivo function and in vitro wear simulation.  Journal of Orthopaedic Research, 27(4):540-548, 2009.
  4. Benson LC, DesJardins JD, Harman MK, LaBerge M:  Effect of stair descent loading on ultra-high molecular weight polyethylene wear in a force-controlled knee simulator.  Proc. IMechE, Part H: Journal of Engineering in Medicine, 216 409-418, 2002.
Trauma
  1. Danesi V, Cristofolini L, Stea S, Traina F, Beraudi A, Tersi L, Harman M, Viceconti M: Re-use of explanted osteosynthesis devices:  A reliable and inexpensive reprocessing protocol.  Injury, 42(10): 1101-1106, 2011.
Surgical Navigation
  1. Harman MK, Banks SA, Kirschner S, Lützner J:  Prosthesis alignment affects axial rotation motion after total knee replacement:  A prospective in vivo study combining computed tomography and fluoroscopic evaluations.  Submitted to BMC Musculoskeletal Disorders, January 2012.
  2. Hodge WA, Schmitt S, Harman MK, Mitchell KH, Banks SA:  Intraoperative assessment of bone cuts to guide surgical technique during total knee arthroplasty.  Journal of Bone and Joint Surgery, 89-A(Suppl 3):137-143, 2007.
Arthritis- Articular Cartilage- Bone Mechanics
  1. Hodge WA, Harman MK, Banks SA:  Patterns of knee osteoarthritis in Arabian and American populations.  Journal of Arthroplasty, 24(3):448-453, 2009.
  2. Harman MK, Banks SA, Hodge WA, TDV Cooke:  Wear patterns in osteoarthritic knees:  What do they tell us about knee kinematics?  Arabian Orthopaedic News, 5:9-10, 2002.
  3. Harman MK, Markovich GD, Banks SA, Hodge WA: Wear patterns on tibial plateau from varus and valgus osteoarthritic knees. Clinical Orthopaedics and Related Research, 352:149-158, 1998.
  4. Bachus KN, Harman MK, Bloebaum RD: Stereoscopic analysis of trabecular bone orientation in proximal human tibias. Cells & Materials, 2(1):13-20, 1992.
Ligaments
  1. Klos TVS, Harman MK, Habets RJE, Devilee RJJ, Banks SA: Locating femoral graft placement from lateral radiographs in anterior cruciate ligament reconstruction: A comparison of three methods of measuring radiographic images. Arthroscopy, 16(5):499-504, 2000.
  2. Klos TVS, Harman MK, Devilee RJJ, Banks SA, Cook FF: Patellar tendon graft position after anterior cruciate ligament reconstruction: Interobserver variability on lateral radiographs. Acta Orthopaedica Scandinavica, 70(2):180-184, 1999.
  3. Klos TVS, Harman MK, Devilee RJJ, Habets RJE: Interobserver variation in the assessment of roentgenograms for reconstruction of the anterior cruciate ligament. Knee Surgery, Sports Traumatology, Arthroscopy, 6(4):258-259, 1998.
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