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Long term follow-up of “Nexel” total elbow replacement

Current Research
Long term follow-up of “Nexel” total elbow replacement

Background

The Nexel is a recent implant and there are few studies that show how it behaves in the long term with osteolysis

Total Elbow Arthroplasty (TEA). Some of the known modes of failure of TEA are septic loosening, polyethylene wear, osteolysis around the implant and peri prosthetic fracture.

Possible mechanisms for osteolysis are believe to be polyethylene wear secondary to poor implant positioning and edge loading of the polyethylene, flexion impingement, creation of debris and secondary foreign body reaction and component polymethylmethacrylate surface finish (Jeon, Morrey, & Sanchez-Sotelo, 2012).

Loosening of the ulna component is a major cause of revision in Total Elbow Arthroplasty (TEA). The Nexel total elbow arthroplasty was developed with a new bearing design that allows greater contact area with better load sharing and lower edge loading compared to the Coonrad/Morrey arthroplasty (King, et al., 2019).

There is although a potential for impingement in the extreme of range of motion of the elbow in extension and flexion which can produce macroparticles and secondary, increased rate of osteolysis. We hypothesize that the osteolysis rate around the prosthesis will be overall the same when care is taken during the procedure to avoid impingement.

The Nexel prosthesis is a recent implant and there are no available studies to show how it is behaving in the long term with osteolysis. Elbow arthroplasty is not a frequent procedure. We want to use this as an opportunity to review our results and to share our experience with this implant.

Objectives

PRIMARY OBJECTIVES:

  • To determine osteolysis that has occurred around the Nexel prosthesis up to a 5 year mark. This will be achieved by two independent observers reviewing the X rays of such patients and comparing the lucency rate and progression around the prosthesis.

SECONDARY OBJECTIVES:

  • To verify which, if any, patient related factors (BMI, hand dominance, underlying pathology, sex or age at the time of surgery) and surgical related factors (radial head replacement or resection, revision surgery, visible impingement) are related to osteolysis around the implants.

Design

This is a retrospective chart and radiological review plus prospective follow up of all patients who underwent Nexel total elbow arthroplasty by a single surgeon between 2013 and 2019. Radiological review of the most recent x-rays (which are at least 2 years post-op) will be conducted by 3 independent upper limb orthopaedic surgeons. The surgeons will receive deidentified X-rays and follow a standardised assessment form to complete based on the Wrightington method.

Study Procedure

Patients will be identified by the unique Medicare Item number for the procedure of interest within the specified date range. The following will be recorded:

  • Age at time of surgery
  • Whether surgery was primary or revision
  • Other procedures done at the same time (eg removal of hardware, neurolysis etc)
  • Hand dominance
  • Sex
  • BMI
  • Aetiology in cause for elbow arthritis

The Nexel total elbow form #11 – Physician Radiographic Assessment form (published by the prosthesis manufacturer, Zimmer) will be used by the independent observers to qualify and quantify osteolysis on the X-ray.

Patients will be contacted and asked to repeat an X-ray if their most recent scan was not done within 12 months. They will also be asked to complete three outcome scores either online or by paper and post:

  1. The Mayo Elbow Performance Score
  2. The Oxford Elbow Score

Inclusion Criteria

  • Patients who underwent primary Nexel total elbow replacement by a single surgeon (Dr Jeffery Hughes)
  • Patients who were capable of and gave informed consent to participate

Exclusion Criteria

  • Patients with congenital deformity of the elbow
  • Patients incapable of or unwilling to provide informed consent

Ethics and Governance

Approved by St Vincent’s Hospital Human Research Ethics Committee. HREC reference  2020/ETH00320.

Status

Data analysis.

References

  • Jeon, I.-H., Morrey, B. F., & Sanchez-Sotelo, J. (2012). Ulnar component surface finish influenced the outcome of primary Coonrad-Morrey total elbow arthroplasty. Journal of Shoulder Elbow Surgery, 21:1229-1235.
  • King, E. A., Favre, P., Eldemerdash, A., Bischoff, J. E., Palmer, M., & Lawton, J. (2019). Physiological Loading of the Coonrad/Morrey, Nexel, and Discovery Elbow Systems: Evaluation by Finite Element Analysis. Journal of Hand Surgery – American, 61.e1-61.e9.
  • Mansat, P., Bonnevialle, N., Rongieres, M., Mansat, M., Bonnevialle, P., & (SOFEC), t. F. (2013). Results with a minimum of 10 years follow-up of the Coonrad/Morrey total elbow arthroplasty.Orthopaedics & Tramatology: Surgery & Research, 99:S337-S343.
  • Puskas, G. J., Morrey, B. F., & Sanchez-Sotelo, J. (2014). Aseptic loosening rate of the humeral stem in the Coonrad-Morrey total elbow arthroplasty. Does size matter? Journal of Shoulder and Elbow Surgery, 23: 76-81.
  • Roth, E., & Chew, F. S. (2015). Imaging of Elbow Replacement Arthroplasty. Seminars in Musculoskeletal Radiology, 19:60-66.
  • Sanchez-Sotelo, J. (2017). Primary elbow arthroplasty: problems and solutions. Shoulder & Elbow, 9(1):61-70.

sydney-shoulder-research-institute-projects

Lead Investigator:

Dr Jeffery Hughes

Commenced:

2021

Category:

Current Projects

In Research - Current

Biomechanical cadaveric study on displacement following AC Joint stabilisation: a comparison of three constructs

In Research - Current

Long term follow-up of “Nexel” total elbow replacement

In Research - Current

Reverse Total Shoulder Arthroplasty: Comparative Study of New Technologies

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Muscle advancement in massive rotator cuff repair