A preclinical animal study published in Muscles, Ligaments and Tendons Journal confirms the ability of the Rotation Medical bioinductive implant to generate reproducibly a layer of dense, regularly-oriented connective tissue (histologically similar to tendon) over the surface of a rotator cuff tendon in a sheep model.
- Rapid incorporation of the collagen scaffold by host tissues
- Scaffold stimulated both an inductive and conductive response
- Consistent production of a dense, regularly-oriented, connective tissue layer suggests functional adaptation, remodeling and maturation
- Excellent integration into bone with a fibrocartilagenous transition zone reminiscent of a normal direct insertion
- No histologic evidence of a foreign body or inflammatory response at any time for any of the animals
- Histologic response of the host remained stable at 1 year
The bioinductive implant was placed on the superior surface of the sheep infraspinatus tendon.
The implant rapidly and consistently induced a layer of highly-aligned, connective tissue.
By 12 weeks, the implant had induced the formation of a layer of dense, well-integrated and regularly-oriented collagenous tissue that significantly increased the thickness of the native tendon.
At 26 weeks the implant was completely absorbed leaving a stable layer of mature tendon-like tissue over the surface of the host tendon. The maturing tissue histology resembled dense, regularly-oriented connective tissue.
At 26 weeks, all remnants of the implant were gone and the new tissue (NT) was well- integrated into the native bone (NB)
There was excellent integration into bone with a fibrocartilagenous transition zone at 26 weeks
Tissue continued to remodel over time without evidence of an inflammatory response
The histologic response demonstrated functional remodeling of the tissue at 52 weeks
• The maturing tissue histologically resembled tendon-like, (dense, regularly-oriented) connective tissue
• The mean thickness of the new tissue was 86% of the thickness of the underlying rotator cuff tendon.