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The KineSpring(®) Knee Implant System: an implantable joint-unloading prosthesis for treatment of medial knee osteoarthritis.

ABSTRACT: Symptomatic medial compartment knee osteoarthritis (OA) is the leading cause of musculoskeletal pain and disability in adults. Therapies intended to unload the medial knee compartment have yielded unsatisfactory results due to low patient compliance with conservative treatments and high complication rates with surgical options. There is no widely available joint-unloading treatment for medial knee OA that offers clinically important symptom alleviation, low complication risk, and high patient acceptance. The KineSpring(®) Knee Implant System (Moximed, Inc, Hayward, CA, USA) is a first-of-its-kind, implantable, extra-articular, extra-capsular prosthesis intended to alleviate knee OA-related symptoms by reducing medial knee compartment loading while overcoming the limitations of traditional joint-unloading therapies. Preclinical and clinical studies have demonstrated excellent prosthesis durability, substantial reductions in medial compartment and total joint loads, and clinically important improvements in OA-related pain and function. The purpose of this report is to describe the KineSpring System, including implant characteristics, principles of operation, indications for use, patient selection criteria, surgical technique, postoperative care, preclinical testing, and clinical experience. The KineSpring System has potential to bridge the gap between ineffective conservative treatments and irreversible surgical interventions for medial compartment knee OA.

SUBMITTER: Clifford AG

PROVIDER: S-EPMC3663478 | biostudies-other | 2013

REPOSITORIES: biostudies-other

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The KineSpring(®) Knee Implant System: an implantable joint-unloading prosthesis for treatment of medial knee osteoarthritis.

Clifford Anton G AG Gabriel Stefan M SM O'Connell Mary M Lowe David D Miller Larry E LE Block Jon E JE

Medical devices (Auckland, N.Z.) 20130517

Symptomatic medial compartment knee osteoarthritis (OA) is the leading cause of musculoskeletal pain and disability in adults. Therapies intended to unload the medial knee compartment have yielded unsatisfactory results due to low patient compliance with conservative treatments and high complication rates with surgical options. There is no widely available joint-unloading treatment for medial knee OA that offers clinically important symptom alleviation, low complication risk, and high patient ac ...[more]

PMID: 23717052

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Project description:BackgroundMedial knee osteoarthritis (OA) typically occurs with excessive mechanical load within the medial compartment, resulting in degeneration of the articular cartilage.PurposeA novel extracapsular implant (Latella Knee Implant) has been developed to unload the medial compartment of the knee. The implant displaces the iliotibial band (ITB) over the lateral femoral condyle, thereby increasing its effective moment arm, resulting in a transfer of load from the medial compartment to the lateral compartment of the knee. A cadaveric study was performed to evaluate the effect of altering the moment arm of the ITB on knee biomechanics.Study designControlled laboratory study.MethodsA 6-degrees-of-freedom robotic testing system was utilized to measure medial and lateral compartment loads in 8 fresh-frozen cadaveric knees at various ITB loads and knee flexion angles. Measurements were made with and without the implant in place. The system measured the compartment forces at flexion angles between 0° and 30° under 3 simulated loading conditions (300 N quadriceps, 100 N hamstrings, and [1] 0 N ITB, [2] 50 N ITB, [3] 100 N ITB).ResultsLateral displacement of the ITB between 15 and 20 mm resulted in medial compartment unloading between 34% and 65%.ConclusionUnloading the medial compartment with this novel implant has the potential to address the treatment gap for patients with medial knee OA.Clinical relevanceCurrently, there exists a treatment gap for patients with medial compartment OA who have exhausted conservative management but whose disease and symptoms do not warrant more invasive surgical procedures. An extracapsular implant to unload the medial compartment could fill this treatment gap by providing patients and surgeons with a less invasive option for early to mid-stage OA. Unloading the medial compartment may alleviate pain and improve function, allowing patients with early-stage medial OA to remain active longer prior to considering more invasive options such as arthroplasty.

Project description:BackgroundSPECT-CT using radiolabeled phosphonates is considered a standard for assessing bone metabolism (e.g., in patients with osteoarthritis of knee joints). However, SPECT can be influenced by metal artifacts in CT caused by endoprostheses affecting attenuation correction. The current study examined the effects of metal artifacts in CT of a specific endoprosthesis design on quantitative hybrid SPECT-CT imaging. The implant was positioned inside a phantom homogenously filled with activity (955 MBq 99mTc). CT imaging was performed for different X-ray tube currents (I = 10, 40, 125 mA) and table pitches (p = 0.562 and 1.375). X-ray tube voltage (U = 120 kVp) and primary collimation (16 × 0.625 mm) were kept constant for all scans. The CT reconstruction was performed with five different reconstruction kernels (slice thickness, 1.25 mm and 3.75 mm, each 512 × 512 matrix). Effects from metal artifacts were analyzed for different CT scans and reconstruction protocols. ROI analysis of CT and SPECT data was performed for two slice positions/volumes representing the typical locations for target structures relative to the prosthesis (e.g., femur and tibia). A reference region (homogenous activity concentration without influence from metal artifacts) was analyzed for comparison.ResultsSignificant effects caused by CT metal artifacts on attenuation-corrected SPECT were observed for the different slice positions, reconstructed slice thicknesses of CT data, and pitch and CT-reconstruction kernels used (all, p < 0.0001). Based on the optimization, a set of three protocols was identified minimizing the effect of CT metal artifacts on SPECT data. Regarding the reference region, the activity concentration in the anatomically correlated volume was underestimated by 8.9-10.1%. A slight inhomogeneity of the reconstructed activity concentration was detected inside the regions with a median up to 0.81% (p < 0.0001). Using an X-ray tube current of 40 mA showed the best result, balancing quantification and CT exposure.ConclusionThe results of this study demonstrate the need for the evaluation of SPECT-CT protocols in prosthesis imaging. Phantom experiments demonstrated the possibility for quantitative SPECT-CT of bone turnover in a specific prosthesis design. Meanwhile, a systematic bias caused by metal implants on quantitative SPECT data has to be considered.

Project description:ObjectivesThis systematic review aimed to determine the effects of neuromuscular gait modification strategies on indicators of medial knee joint load in people with medial knee osteoarthritis.MethodsDatabases (Embase, MEDLINE, Cochrane Central, CINAHL and PubMed) were searched for studies of gait interventions aimed at reducing medial knee joint load indicators for adults with medial knee osteoarthritis. Studies evaluating gait aids or orthoses were excluded. Hedges' g effect sizes (ES) before and after gait retraining were estimated for inclusion in quality-adjusted meta-analysis models. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.ResultsSeventeen studies (k = 17; n = 362) included two randomised placebo-controlled trials (RCT), four randomised cross-over trials, two case studies and nine cohort studies. The studies consisted of gait strategies of ipsilateral trunk lean (k = 4, n = 73), toe-out (k = 6, n = 104), toe-in (k = 5, n = 89), medial knee thrust (k = 3, n = 61), medial weight transfer at the foot (k = 1, n = 10), wider steps (k = 1, n = 15) and external knee adduction moment (KAM) biofeedback (k = 3, n = 84). Meta-analyses found that ipsilateral trunk lean reduced early stance peak KAM (KAM1, ES and 95%CI: -0.67, -1.01 to -0.33) with a dose-response effect and reduced KAM impulse (-0.37, -0.70 to -0.04) immediately after single-session training. Toe-out had no effect on KAM1 but reduced late stance peak KAM (KAM2; -0.42, -0.73 to -0.11) immediately post-training for single-session, 10 or 16-week interventions. Toe-in reduced KAM1 (-0.51, -0.81 to -0.20) and increased KAM2 (0.44, 0.04 to 0.85) immediately post-training for single-session to 6-week interventions. Visual, verbal and haptic feedback was used to train gait strategies. Certainty of evidence was very-low to low according to the GRADE approach.ConclusionVery-low to low certainty of evidence suggests that there is a potential that ipsilateral trunk lean, toe-out, and toe-in to be clinically helpful to reduce indicators of medial knee joint load. There is yet little evidence for interventions over several weeks.

Dataset Information

The KineSpring(®) Knee Implant System: an implantable joint-unloading prosthesis for treatment of medial knee osteoarthritis.

Publications

The KineSpring(®) Knee Implant System: an implantable joint-unloading prosthesis for treatment of medial knee osteoarthritis.

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