Clinical Studies
At LRE System Ltd, we are dedicated to advancing the understanding of our product and the benefits to patients, surgeons and hospitals, through clinical studies and post market clinical evaluation.
Summary of LRE clinical evidence outcomes against safety and performance
- 100% survivorship up to a maximum of 9.4 years (8.6 years mean; Watkins et al).
- Overall complication rate reported in the literature of 6.3%. This compares well with complication rates for TEA reported in systematic reviews which showed complication rates ranging from 20-29%.
- Clinical data demonstrates significant improvements in range of movement, consistent with the requirements for resumption of normal daily activity.
- Statistically significant improvements in PROMS were reported in four retrieved articles, consistent with good to excellent performance outcomes.
Following is a list of Clinical Studies & Related Science on the Lateral Resurfacing Elbow:
- POOLEY J. “Unicompartmental elbow replacement: development of a lateral replacement (LRE) arthroplasty”. Tech Shoulder Elbow Surg. 2007; 8:204- 212
- GIANNICOLA G, ANGELONI R, MONTOVANI A, REBUZZI E, MEROLLA G, GRECO A, SACCHETTI FM, ITALO N, CINOTTI G, POSTACCHINI F. “Open debridement and radiocapitellar replacement in primary and post-traumatic arthritis of the elbow: a multicentre study”. J Shoulder Elbow Surg 2012; 21,456-463
- WATKINS CEL, ELSON DW, HARRISON JWK, POOLEY J. “Long-term results of the lateral resurfacing elbow arthroplasty”. Bone Joint Journal 2018; 100-B:388-45
- KACHOOEI AR, HEESAKKERS NAM, HEIJINK A, THE B, EYGENDAAL D. “Radiocapitellar prosthetic arthroplasty: short-term to midterm results of 19 elbows”. J Shoulder Elbow Surg. 2018; 27, 726-732
- GIANNICOLA G, CALELLA P, BIGAZZI P, MANTOVANI A, SPINELLO P, CINOTTI G. “A multicentre prospective study on two different implants”. Bone Joint Journal 2019; 101-B:1362-1369