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Kineflex (Centurion) Lumbar Disc Prosthesis: Insertion Technique and 2-Year Clinical Results in 100 Patients

Ulrich R. Hähnle, MD, FCS (Ortho),1,2 Ian R. Weinberg, MD, FCS (Neuro),2 Karen Sliwa, MD, PhD,3 Barry MBE Sweet, MD, PhD,1 Malan de Villiers, PhD4

1Department of Orthopedic Surgery, University of the Witwatersrand, Johannesburg, South Africa 2Linksfield Park Clinic, Johannesburg 3Department of Medicine, University of the Witwatersrand, Johannesburg, South Africa 4Department of Mechanical Engineering, University of Potchefstrom, Potchefstrom, South Africa; Southern Medical, Wapadrand, South Africa

Abstract 

Background

The Kineflex lumbar disc is a mechanical, unconstrained, re-centering disc prosthesis developed in South Africa. The first implantation took place in October 2002. We present a single-center, prospective, longitudinal study of the first 100 patients treated with the Kineflex lumbar disc. Our objective was to evaluate the insertion technique, clinical outcomes, and patient satisfaction at 2 years postimplantation in 100 consecutive patients with 132 (68 single- and 32 2-level) Kineflex lumbar disc replacements.

Methods

We determined the exact central placement of all disc implants in the coronal and midsagittal planes. We measured clinical outcome with the Oswestry disability index (ODI), our own questionnaire, and the time needed to return to work. All patients received radiological and clinical follow-up assessments for 2 years after the index procedure.

Results

Forty-three patients were female. The mean age of the patients at operation was 44.9 years (range, 23–63 years). Postoperative hospitalization averaged 2.8 days (range, 2 to 8 days). All patients who were employed before surgery returned to work 31±16.8 days after the operation. Fifty-six percent of operated disc levels had intervertebral disc heights of less than 5mm. A 2-year clinical outcome was available for 98 of the 100 patients (58 excellent, 30 good, 7 fair, 3 poor). The ODI score improved from 47.8±16.0 preoperatively to 14.2±14.0 (P<.01) at 2 years. At 2 years, 95% of disc implants were radiologically in the ideal position. The insertion technique, with a released prosthetic mechanism for final placement, allowed ideal placement in the sagittal plane in 98% of discs. The radiographic placement accuracy achieved was equal in patients with preoperative intervertebral disc height below and above 5mm.

Conclusions

Good short-term clinical results were achieved with the Kineflex disc in a heterogeneous patient group with a high number of patients with advanced disc degeneration, severe disc space narrowing, and lumbar flat-back deformity. In this cohort, accurate implant placement could be achieved in our first 100 patients.

Clinical Relevence

This is the first report on the Kineflex mechanical lumbar disc prosthesis.

keywords: 
Kineflex disc, degenerative disc disease, lumbar disc prosthesis, insertion technique, unconstrained disc prosthesis, Oswestry disability index
Volume 1 Issue 1
doi: 
10.1016/S1935-9810(07)70044-0