3A ODEP. Preserving the natural anatomy and restoring patient biomechanics

Transcription

1 Product overview

2 Patient demographics and expectations have changed [1]. Being younger, more active and wanting to return to their normal way of life quicker and without compromise, these patients require an implant that overcomes the limitations of conventional hip replacement. MiniHip is designed to give patients all the advantages of a traditional total hip replacement with the added benefit of preserving the natural anatomy, offering a pre-primary solution that is the ideal intervention for a patient requiring treatment options into the second, third and fourth decade. Preserving the natural anatomy and restoring patient biomechanics 3A ODEP rating MiniHip has shown 99.5% survivorship at 3 years for aseptic loosening and has been awarded 3A rating for clinical excellence by the Orthopaedic Data Evaluation Panel (ODEP)*. 2

3 Conserving bone Preserving soft tissue Restoring biomechanics Responsible Innovation 3

4 Conserving bone MiniHip allows for greater bone conservation at the time of operation and in the long term. Initial bone conservation 1. Trochanter conserving MiniHip is designed to follow the natural anatomy: there is no lateral flare and the entry point avoids the greater trochanter Neck preserving MiniHip neck resection is intended to preserve the neck and calcar to assist in promoting more natural physiological loading, unlike conventional THR [2]. 2. Diaphyseal sparing The length and design of MiniHip allows for more bone preservation of the medullary canal than traditional THR. In addition, the distal tip of MiniHip is polished to reduce the risk of an increase in bone mineral density from occurring at this point. 2 MiniHip is designed to preserve significantly more bone stock in the femoral neck, trochanter and diaphyseal region in comparison to other short and conventional stems, helping to promote more natural, physiological loading. 3A ODEP rating 4

5 MiniHip offers a pre-primary solution that is the ideal intervention for a patient requiring treatment options into the second, third and fourth decade. Long-term bone conservation Physiological loading MiniHip loads the femur more naturally than a conventional THR in terms of medial strain [3], tensile strain, compressive strain [4] and strain energy density [2]. This will help facilitate good quality proximal bone stock into the future (mm) Unimplanted MiniHip 5% difference (microstrain) Unimplanted conventional 30% difference Unimplanted MiniHip Fully HA coated THR Finite element analysis shows compressive strain in the femur for an unimplanted femur, MiniHip and a conventional THR, (increasing areas of blue represent increased compression). Conventional THR Unimplanted MiniHip Measurement of medial strain in the proximal femur, comparing an unimplanted femur with a MiniHip and conventional THR. Responsible Innovation 5

6 Preserving soft tissue MIAA (Minimally Invasive Anterior Approach) Instrumentation MiniHip is an ideal implant for use with a direct anterior approach, soft tissue sparing procedure, as it follows the natural anatomy by going round the corner of the calcar. Direct anterior approach patients have earlier discharge and mobilisation as compared to patients who receive the posterior approach [5]. MiniHip implant and MIAA instrumentation systems are ideally suited to direct anterior, helping to facilitate patient recovery and a faster return to activity. 3A ODEP rating 6

7 MiniHip and direct anterior, an ideal synergy Responsible Innovation 7

8 Restoring biomechanics Femoral varus/valgus anatomies MiniHip offers a unique way of restoring biomechanics for different patient anatomies. MiniHip is a CT based design and is not constrained in its placement by a conventional, intrusive lateral profile. This provides a unique solution to restoring the biomechanics of multiple patient anatomies. Early and mid-term clinical results with MiniHip illustrate reproducibility of: CCD to less than 0.6degrees [6] Femoral offset to less than 3mm [6] Leg length to less than 1mm [6] varus anatomy neutral anatomy valgus anatomy 3A ODEP rating 8

9 Femoral anteversion MiniHip offers the ability to restore anteversion by retaining a portion of the femoral neck. The size and shape of the stem, coupled with the retention of the femoral neck enables MiniHip to restore the biomechanics of multiple anatomies including highly anteverted femurs [7]. Responsible Innovation 9

10 Conserving bone MiniHip is designed to minimise bone loss during the time of operation, and promote physiological loading to maintain good bone stock into the long term. Preserving soft tissue Ideally suited to the direct anterior approach, MiniHip is designed to be less invasive to soft tissues, potentially leading to faster patient recovery. Restoring biomechanics With an implant profile that preserves the femoral neck and follows the natural curvature of the medial calcar, MiniHip is designed to restore biomechanics for multiple anatomies. 3A ODEP rating 10

11 Responsible Innovation 11

12 References: 1. Kurtz SM, Lau E, Ong K, Zhao, Kelly M, Bozic KJ. Future young patient demand for primary and revision joint replacement: national projections from 2010 to Clinical Orthopaedics and Related Research 2009 Oct;467(10): Simpson D, Yeoman M, Lowry C, Cizinauskas A, Vincent G, Jerosch J, Collins S. Load transfer into the proximal femur: why short stems are more advantageous with respect to the mechanical environment. ISB 2011 Brussels. 3. Simpson D, Yeoman M, Lowry C, Cizinauskas A, Vincent G, Jerosch J, Collins S. Load transfer into the proximal femur: why short stems are more advantageous with respect to the mechanical environment. AAOS Yeoman M, Cizinauskas A, Lowry C, Vincent G, Collins S, Simpson D. Short stems are less likely to lead to bone resoption: bone remodelling following THR. Bath biomechanics symposium Martin CT, Pugely AJ, Gao Y, Clark CR. A comparison of hospital length of stay and short term morbidity between the anterior and posterior approaches to total hip arthroplasty. Journal of Arthroplasty 2013 May;28(5): Jerosch J, Grasselli C, Kothny C. Early and mid term clinical results with MiniHip short stem replacement. OUP 2012:1(5): Kreuzer S. 43rd annual advances in Arthroplasty care. Harvard *ODEP (Orthopaedic Data Evaluation Panel) is an independent body commissioned by the UK s National Institute for Health and Care Excellence (NICE) in ODEP independently assesses whether a device has reached a specified clinical benchmark for implant survivorship and translates these into ratings: greater than 97% survivorship at 3 years (ODEP rating 3A or 3B); greater than 95% survivorship at 5 years (ODEP rating 5A or 5B); greater than 93% survivorship at 7 years (ODEP rating 7A or 7B); greater than 90% survivorship at 10 years (ODEP rating 10A, 10B or 10C). The Corinium Centre Cirencester, GL7 1YJ, UK t: +44 (0) f: +44 (0) e: info@coringroup.com (The number in the rating relates to the average follow-up in years and the letter relates to the quality of data: A = strong evidence, B = reasonable evidence, C = weak evidence.) For more information, go to: % Printed on Cocoon 100 which contains 100% total recycled fibre and is produced at a mill which holds the ISO for Environmental Management Systems. The pulp is bleached using Elemental Chlorine Free processes. BONIT is a registered trademark of DOT GmbH BIOLOX delta is a registered trademark of CeramTec 2013 Corin P No I919 Rev2 10/2013 ECR 12839