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Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 215 - 215
1 May 2006
Goldhahn J Schwyzer H Drerup S Simmen B
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Introduction: The restoration of the anatomical centre of rotation can be achieved in total shouder arthroplasty (TSA) using newly developed modular shoulder prosthesis (Promos), anchored with rectangled, non-cemented shaft. Especially patients with complex pathological destructions due to rheumatoid arthritis (RA) should benefit from this feature. So far it was not clear, whether the concept works in their poor bone stock too. The aim of this prospective study was to assess outcome and complication rate of patients with RA and Omarthrosis (OA) after TSA with Promos prosthesis.

Materials and Methods: All patients that received a TSA either due to OA or due to RA were prospectively recorded and evaluated 6 and 12 month after surgery. Functional outcome and quality of life was charged with a standardized scores set (DASH, Constant-Murley score, SPADI, ASES and SF-36, all normalized from 0=worst to 100=best) and compared with normative data as well as with data from a retrospective control, operated with an Aequalis prosthesis. Number and types of complications were recorded and the radiological findings evaluated from an independent observer.

Results: Although RA patients (n=8) did not reach the same functional results than OA patients (n=53) operated with Promos“ prostheses (DASH 78 in OA vs. 67.4 in RA, CS 74.3 in OA vs. 67.6 in RA) the difference between both indication groups was significantly smaller than for the Aequalis prosthesis (p< 0.001). Whereas RA patients after Promos“ prosthesis revealed functional deficits ranging from −6.7 in the Constant score, −10.6 in the DASH to −11.1 in the SPADI, this difference was larger in the Aequalis group with −16.4 in the Constant score, −25.2 in the DASH and −19.6 in the SPADI. Radiological findings and complication rate did not differ significantly.

Discussion: The newly developed modular design of the Promos prosthesis seems to offer better features to restore the complex anatomy, especially in RA patients. The required cementless shaft anchorage is not associated with a higher complication risk. Methodological issues limit the comparison of the two studies and the differences have to be proven in a prospective, comparative study therefore.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 209 - 209
1 May 2006
Goldhahn J Drerup S Angst F Simmen B
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Introduction: Patient self-assessment plays a significant rule in the monitoring of patients within clinical studies as well as a separate quality indicator. The self-assessment of function, disease activity and quality of life is known to have a predictive value in the disease progression of rheumatoid arthritis (RA) and other orthopaedic diseases. However, all questionnaires challenge the clinical infrastructure. The questionnaire administration and their processing require still considerable manpower and is a potential source for errors. We analysed the in-house processes, identified the essential requirements and explored possible electronic solution with the aim to reduce necessary manpower and failure sources.

Materials and methods: In a first step we defined a set of questionnaires we want to administer on a regular base. We then evaluated candidate systems with respect to data handling and to further statistic processing. Two years later we re-evaluated the system and possible alternatives. We then paid special attention to scanning features and data export options. Finally we performed reliability and handling tests and a first clinical trial.

Results: The standardized set for shoulder patients comprises 144 items per patients. The set was designed as a four-color print for automatic processing with Qualicare. Four large studies with a total of more than 300 evaluations were performed using Qualicare. Our reevaluation of the system revealed major problems with the line scanner, the data processing in the system and the data export into statistics programs. After intensive search we installed a new scanning system based on an OMR reader that detects regions of interests on the questionnaire (Remark Office). This system allows simple form generation with the PC, the use of bar-code and faster processing. Reliability was more than 0.95 and handling revealed no major problems. Since first trials were successful the new system became the standard for all questionnaires in our department. Discussion: The high amount of variables in patient self-assessment requires automated processing to save manpower and to avoid failures during manual processing. During a three-year period we identified scanning and export options as the key factors for long-term success. The new system (Remark Office) accomplishes both requirements and might serve as the base for large studies or regular quality control.