The concept of long-term reduction is medial compartment load to effectively treat knee OA is fundamentally sound, but no available treatment

is clinically practical for a patient to continue for a sufficient amount of time to realize sustainable symptom amelioration Conservative measures o Body weight loss Lowers knee compressive forces, improves knee function, alleviates knee pain Each 1 kg lost = 4 kg reduction in knee compressive forces Losing 5 kg reduces risk of developing OA by 50% *losing and maintaining can be extremely challenging Only 1/5 ultimately lost 10% or moreand maintain it for >1yr o Orthotics, unloading knee braces Reduce load on medial compartment Consistent and proper use is challenging must be worn 5-10 hrs/day, knee braces are cumbersome & uncomfortable High subject attrition over long term clinical trials o Nonsteroidal anti-inflammatory meds o Hyaluronic acid injections o Physical therapy EFFICACY IN SLOWING DISEASE PROGRESSION IS LIMITED likely because they fail to alter the adverse mechanical environment of the knee and have no effect on medial compartment loading corticosteroids and hyaluronan injections that offer ST pain relief can ultimately encourage greater mechanical loading of medial compartment faster OA progression rate OA predictably but variably progresses in severity over time until operative intervention is needed: o Arthroscopic surgery Arthroscopic lavage and debridgement shown to be no more effective than sham surgery in randomized blind study >1/5 patients require high tibial osteotomy or total knee arthropasty w/in 3 years of undergoing arthroscopic intervention o High Tibial Osteotomy Invasive surgical procedure that involves significant bone removal & reshaping to reduce load transfer across medial compartment Satisfactory initial results, but patient outcome deteriorates Significant procedural risks limit the utility of HTO: infection (2-55%), deep vein thrombosis (1-10%), delayed or non-union (0-14%), peroneal nerve injury (0-20%) o Arthroplasty Standard of care-treatment for end-stage OA Surgically removes the diseased bone & cartilage from the joint, replaces it with artificial joint made of synthetic materials Reliably restores joint function and improves health-related quality of life in patients who are unable to achieve relief from conservative measures Universally recommended among knee OA guidelines but there are limitations: Use for patients <70yrs is controversial theyre at greater risk for prosthesis failure therefore limiting the utility of the procedure

Many patients who are eligible endure knee pain and dysfunction for years/decades in an effort to delay/avoid surgery only 20-33% with severe OA are definitely or probably willing: to consider it IDEALLY, AN INTERVENTION WOULD BE DEVELOPED FOR PATIENTS WHO HAVE EXHAUSTED CONSERVATIVE OPTIONS BUT HAVE NOT YET REACHED THE THRESHOLD FOR INVASIVE SURGERY

KineSpring
Goal: effectively and safely treat OA, eliminate/reduce complications associated with surgery Ideal characteristics for knee OA treatment: o Reversible joint preserving implant, enables rapid patient ambulation & recovery o Reduces medial compartmental loading, doesnt transfer adverse load to lateral/patellofemoral compartments o Effective in relieving pain & improving ROM o High patient acceptance o Compatible w/ lifestyle expectations of most OA patients Minimally invasive knee implant specifically designed to fill therapeutic gap between conservative care & more invasive surgical interventions Consists of titanium alloy femoral & tibial bases, covered cobalt/cobalt chrome alloy absorber that reduces the load on the diseased medial compartment during stance phase of gait Both extra-articular & extra-capsular Implantation is achieved without resection of bone, muscle or ligaments, w.out violation of joint capsule Load absorber is in subcutaneous tissue on medial knee, superficial to MCL Implantation w/out joint invasion = surgical procedure thats reversible option for future explant to reachieve pretreatment state o *sharp contrast to other common treatments: high tibial osteotomy, arthroplasty invasive, permanent, significant anatomical modifications KINEMATICS: o Accommodate natural motions of the knee joint by using 2 ball-and-socket joints o Wide range of normal physiological knee motions Capability for unlimited int/ext rot, 50 varus-valgus angulation, 155 flex/ext movement Absorbs max load of 18kg during full extension o comparable to lower knee adduction moments across a wide range of body weights Reduces chronic medial compartment loading w/out significant increases in lateral compartment loading o comparable to the amount of body weight loss shown to improve function and alleviate knee pain indication patients w/ clinically and/or radiographically established OA who have exhausted conservative nonoperative care, best suited for those w/ moderate to severe degeneration of medial compartment & no more than minimal degeneration in lateral & patellofemoral compartments, but not yet a candidate for total knee arthroplasty or HTO Implantation procedure is advantageous for patients and physicians o general anesthesia, femoral base is attached to medial distal femoral cortex after access through small incision proximal to knee o Absorber and tibial base assembly are positioned subcutaneously thru a small 2nd incision distal to knee assembled to the prepositioned femoral base and attached to the medial proximal tibial cortex o Absorber activation is completed before wound closure implant system & surgical technique allow for early ambulation Technique: novel compared to invasive procedures since all anatomical structures (bone, muscles and ligaments) are left intact this joint preserving procedure allows for normal kinematics w/out compromising future surgical options if subsequent surgery is required it can simply be removed, leaving the joint and surrounding structures intact and undisturbed Biomechanical Results:

o o

Load reduction was evaluated w/ 4 cadaver knees w/ early OA that were subjected to simulated gait in a kinematic test system for investigating knee biomechanics medial & lateral compartment loads were measured using dynamic pressure sensors placed on the tibial plateau distal to the meniscus Medial compartmental loading significantly lower during stance & heel strike and toe-off Total joint load (sum of med + lat) is thus lower with the KineSpring device these outcomes suggest that it effectively lowers medial compartment and overall joint loading, which over time may slow or reverse the progression of OA lateral knee loading No significant difference in medial compartment load reductions significant differences at heel strike (3% of gait) and toeoff (45% of gait) total knee load significant difference in initial loading (13% of gait) and toe-off (45% of gait) swing phase kinespring is passive & implanted and untreated forces are similar

CONCLUSION
KineSpring represents a first-of-its-kind implantable device with potential to bridge the gap between conservative care & surgical interventions in the treatment of knee OA Its ability to decrease medial compartment forces w/out load transfer + its minimal invasiveness & reversibility is unlike any other available treatment Biomechanical testing is encouraging and suggests clinical utility allows patients w/ knee OA to alleviate chronic pain w/out having to resort to irreversible joint-altering surgeries