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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 330 - 330
1 Sep 2012
London N Hayes D Waller C Smith J Williams R
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Introduction

Osteoarthritis (OA) represents a leading cause of disability and a growing burden on healthcare budgets. OA is particularly vexing for young, active patients who have failed less invasive therapies but are not yet candidates for arthroplasty. Often, patients suffering in this wide therapeutic gap face a debilitating spiral of disease progression, increasing pain, and decreasing activity until they become suitable arthroplasty patients. An implantable load absorber was evaluated for the treatment of medial knee OA in this patient population.

Joint overload has been cited as a contributor to OA onset or progression. In response, the KineSpring® System (Moximed, Inc, USA) has been designed to reduce the load acting on the knee. The absorber is implanted in the subcutaneous tissue without violating the joint capsule, thus preserving the option of future arthroplasty. The implant is particularly useful for young, active patients, given the reversibility of the procedure and the preservation of normal flexibility and range of motion.

Methods and Results

The KineSpring System was implanted in 55 patients, with the longest duration exceeding two years. The treated group had medial knee OA, included younger OA sufferers (range 31–68 years), with a mean BMI > 30kg/m2. Acute implant success, adverse events, and clinical outcomes using validated patient reported outcomes tools were recorded at baseline, post-op, 2 and 6 weeks, and 3, 6, 12 and 24 months post-op.

All patients were successfully implanted with a mean procedure time of 76.4 min (range 54–153 minutes). Mean hospital length of stay was 1.7 days (range 1–3 days), and patients recovered rapidly, achieving full weight bearing within 1–2 wks and normal range of motion by 6 weeks. Most patients experienced pain relief and functional improvement with 85% (35/41) reporting none or mild pain on the WOMAC pain subscale and 90% (37/41) reporting functional impairment as none on mild on the WOMAC function subscale at the latest follow-up visit (mean 9.3 ± 3.5 months). Clinically meaningful and statistically significant pain reduction and functional improvement were noted with baseline WOMAC pain scores (0–100 scale) improving from 42.4 to 16.1 (p<0.001) and WOMAC function (0–100 scale) improving from 42.0 to 14.7 (p<0.001) at latest follow-up. Patients reported satisfaction with the implant and its appearance.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 41 - 41
1 Jul 2012
London N Smith J Guy S Hayes D Waller C Williams R
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Statement of Purpose

The UK and Australian clinical experience of an implantable load absorber was reviewed for knee OA patients who have exhausted conservative care, but are not ideal candidates for HTO or arthroplasty due to age, activity level, obesity, or disinclination.

Methods and Results

The load absorber was implanted in 58 patients, with the longest duration exceeding two years. Patients included younger OA sufferers (31-68 years), and had a mean BMI > 30kg/m2. Early surgical experience and adverse events with the device were recorded and clinical outcomes using validated patient reported outcomes tools were collected at baseline, post-op, 2 and 6 weeks, and 3, 6, 12 and 24 month timepoints.

All patients were successfully implanted with a mean surgical time of 76.4 minutes (range 54-153). After a mean hospital stay of 1.7 days (range 1-3), patients resumed full weight bearing within 1-2 weeks and achieved normal range of motion by 6 weeks. Mean WOMAC pain (0-100 scale) improved from 42.4 to 16.1 (p<0.001); mean WOMAC function (0-100 scale) improved from 42.0 to 14.7 (p<0.001). Most patients reported “no or mild” pain (85%) or “no or mild” functional impairment (90%) at last follow-up (9.5 ± 3.5 months). Patients reported high satisfaction with the implant. Initial UK results mirror the positive Australian experience: reduced pain, improved function, and high satisfaction.

Complications arising in the early surgical experience were effectively resolved through revised surgical technique and minor design modifications.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 328 - 328
1 May 2010
Sidhom S Al-Lami M Sturdee S Anderson A Muthukumar N Hughes V Bennett C London N
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Aim: To assess the safety and efficacy of a mini-incision surgical (MIS) approach to knee arthroplasty (TKA) compared to a traditional standard approach.

Background: TKA through less invasive approaches have become increasingly popular in recent years. These range from smaller skin incisions to the ‘quadriceps-sparing’ procedures. Claims of improved recovery time and other clinical/economic advantages have been tempered by concerns about the safety of such procedures. This study was designed to evaluate any potential advantages of a specific approach (MIS) whilst studying peri-operative, radiological and outcome data to examine procedural safety.

Patients and Methods: 80 patients undergoing TKA were randomised to a standard or MIS (mini-midvastus) approach. The latter involved patella subluxation, rather than eversion. The operative, anaesthetic and post-operative treatments were standardised including rehabilitation protocols. Strict discharge criteria were established and independently verified and patients were discharged directly to their homes capable of independent care. Specifically the study evaluated patient demographics, operative time, blood loss and hospital stay. Outcome data including Knee Society Scores, Oxford Knee Scores and SF36 were recorded regularly in the early recovery period and up to 1 year post-operatively. Independent radiological review of implant positioning and alignment was obtained.

Results: There were no significant differences in operative time, blood loss, or other intra-operative data. Accelerated discharge was achieved in both groups (compared to historic data), however the length of stay (LOS) was significantly shorter in the MIS patients (mean – 3.5 days compared with 4.4 days in the standard patients). There was no statistical difference in clinical outcome analyses between the groups.

Discussion: Less invasive approaches to TKA have been reported over recent years but most studies have been anecdotal comparing patient recovery with historic controls which potentially can exaggerate clinical and economic benefits. Concerns have also been raised regarding the safety of these modified procedures. This study demonstrates a reduction in hospital stay and recovery in all patients as a result of accelerated rehabilitation. The MIS patients benefited from an additional significant reduction length of stay compared to controls with no evidence of compromise in terms of safety or efficacy.

Conclusions: This study has demonstrated the safety of the MIS mini-midvastus approach and a clear reduction in hospital length of stay. MIS surgery can offer substantial clinical and economic benefits but procedures must be closely evaluated to ensure equivalent or enhanced outcomes are achieved.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 43 - 43
1 Mar 2009
Tomlinson J Hannon E Sturdee S London N
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Introduction: The use of simultaneous bilateral knee replacement surgery remains controversial–several studies have reported increased rates of complications, and the use of the technique remains in question. However, many of these procedures are not truly simultaneous, meaning it is difficult to draw accurate conclusions on the safety of this technique from the published literature.

Method: A retrospective notes based review of all those patients undergoing bilateral knee replacement surgery between 2000 and 2005 at Harrogate District Hospital was performed. Patients undergoing both unicompartmental (UNI) and total knee replacement (TKR) were included. Procedures were performed by a consultant orthopaedic surgeon and his knee fellow with one scrub team. The post operative morbidity and mortality was assessed both 30 days post operatively and also at six month follow up.

Results: A total of 112 procedures were performed over the five year period. There were no deaths reported within the study group. Within the group there were 3 DVT’s, 2 superficial wound infections and one case of aseptic loosening at six months. Average tourniquet time was 76 minutes for the TKR group and 82 minutes for the UNI group. Average length of stay over the five year period was 8.6 nights (TKR) and 6.6 nights (UNI).

Conclusion: Bilateral truly simultaneous knee replacement surgery is a safe technique with favourable rates of complications. It offers the benefit of improved efficiency with regard to both theatre time and length of hospital stay, which is valuable in the modern climate of economic strain within health services worldwide. It also offers an excellent opportunity to the trainee to operate independently within a controlled environment, and is favoured by patients–offering a single admission and rehabilitation period.