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Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 215 - 215
1 May 2006
Angst F Goldhahn J Aeschlimann A Simmen B
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Background The new concepts of health assessment based on the WHO’s International Classification of Functioning, Disability, and Health (ICF) require the increased use of patient self-rated outcome measurement. There is an extensive body of literature to support the concept that self-rating is far more valid than ‘objective’ parameters such as x-ray findings, range of motion etc. While the value of joint-specific assessment is obvious in rheumatoid arthritis (RA), the need for comprehensive outcome parameters may seem to be less important. We present an exemplary study which compares generic, comprehensive assessment with condition-specific assessment.

Methods In a cross-sectional catamnesis study, the outcomes of patients with RA and posttraumatic (PT) elbows were compared 11 years after total elbow arthroplasty using generic and specific self-rating instruments.

Results Compared to the scores recorded for the 20 PT patients, the 59 RA patients achieved mean scores of 105.6% on the Short Form 36 (SF-36) Mental Component Summary, 82.5% on the Patient Related Elbow Evaluation (PREE) function, 69.5% on the Disability of the Arm, Shoulder and Hand (DASH) function, and 60.2% on the SF-36 physical functioning (a higher score means better health).

Conclusions The elbow-specific PREE revealed little functional deficits for RA compared with PT, the arm-specific DASH showed moderate, and the generic, comprehensive SF-36 demonstrated large functional deficits, whereas psychosocial health was comparable for RA and PT. Post-interventional outcomes may be similar when focusing on a specific condition or joint. Functional deficits and holistic health can only be captured by comprehensive measurement when dealing with systemic polyarticular affection like RA.


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.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 208 - 208
1 May 2006
Kolling C Goldhahn J Simmen B
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Since the successful introduction of National arthroplasty registers by the Scandinavian countries, requirements in arthroplasty research have changed from pure implant survival rates to functional results and quality of life aspects. More patient data are required to address these areas. The goal of our international arthroplasty register survey was to determine key factors for an effective database as source for these scientific analyses.

In the first step, we identified and analysed all available arthroplasty registers via extensive literature and web searches. The preliminary data were validated by sending out a standardized questionnaire with questions regarding goals, organization, funding, documentation, data handling and output of the register. The responses were checked and, if necessary, further information requested via phone.

So far we received detailed information from nine arthroplasty registers worldwide. Only two registers collect data from clinical scores or questionnaires in addition to data for the survival rate. The majority of registers are maintained by the national orthopaedic associations, others like Finland by governmental organizations. The legal boundary conditions vary considerably, e.g. in Finland participation is mandatory, while patient tracking via Social security numbers is not possible in all countries. The rate of participating hospitals ranges up to 100%: 510 surgeons in Canada (72%) – 43 hospitals in Denmark (100%). The preferred locations are hip and knee, the preferred documentation method is paper-based, several registers offer online access or other types of electronic data transfer. In return, surgeons receive a regular feedback from the registers, mostly in form of annual reports. Only a few registers allow the surgeons to have online access to their data in the database. Funding is still of major concern. Although the definition of annual total costs varies, they stay far below 500,000 dollars. Examples of funding sources are the government, National Orthopaedic Associations, grants, a levy placed on the sale of implants, and others.

For the completeness of the collected data, a high rate of participating hospitals as well as a high follow-up-rate is crucial. This can only be guaranteed with substantial funding, governmental support for setting up an adequate framework and the compliance of the participating hospitals. New ways of data collection and processing might help to increase patient and hospital compliance.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 214 - 214
1 May 2006
Schindele S Steinbach A Herren D Simmen B
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Introduction: Silicon-implant-arthroplasty in cases of severe destruction of the radiocarpal joint was a routinely used procedure in rheumatoid arthritis to restore mobility and function. However in many cases an implant failure with a fracture rate of up to 50% with massive synovitis and a severe carpal collaps must be documented. Main problem is the extensive bone loss which makes further procedures difficult. Revision-wrist-arthrodesis with bone grafting (iliac bone, allograft or free fibula-graft) is the commonly used procedure. Therefore non-union in these cases is documented in up to 40%.

Material and Methods: Between 1999 and 2003 we performed in 2 cases of severe seropositive rheumatoid arthritis and in one case of psoriatic wrist joint destruction with extensive bone loss only a revision arthroplasty with debridement and insertion of a new Swanson silicon implant. At the time of revision mean age was 61 years and primary silicon arthroplasty was done 11 years ago. In one case a decompression of the median nerve in the carpal canal was necessary. In one case a transposition of the ECU to ECRB was performed to neutralize the ulnar drift of the remaining carpus.

Results: In all patients a good mobility in the wrist with pain free function could be achieved. All patients were satisfied with this procedure. Clinical, subjective and radiological results are presented.

Conclusion: Revision after silicon-wrist arthroplasty with severe bone loss without or only minimal carpal bone stock and a thin trumpet-like distal radius is difficult. Revision arthrodesis often ends in a non-union despite substantial bone-grafts. Debridement and revision with a new silicon implant is easy to perform and respectable function and a pain free situation might be achieved.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 133 - 134
1 Mar 2006
John M Angst F Pap G Flury M Herren D Schwyzer H Simmen B
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Introduction: In the evaluation of the major joints, self assessment tools have become wide spread aiming at a more precise quantification of joint function. Different tools have been developed for the elbow joint. However, there are only few data on the relationship between subjective self-assessment of joint function and objective measures.

We developed a comprehensive assessment set for the evaluation of subjective elbow function and objective clinical findings and investigate long-term results after implantation of GSB III Elbow arthroplasties in a first study. The PREE-G was cross-culturally adapted, following the recommendations of the American Association of Orthopedic Surgeons.

Material and Methods: 79 patients (56 female, 23 male, mean age 64 years) after elbow arthroplasty between 1984 and 1996 due to rheumatoid (59) or posttraumatic (20) arthritis underwent an assessment of the joint function using the PREE, the Short Form 36 (SF-36), the Disabilities of Arm, Shoulder, Hand (DASH)) and the modified American Shoulder and Elbow Surgeons (mASES) for a clinical evaluation. In 62 patients implantation was performed unilaterally and in 17 patients bilaterally, resulting in 96 elbow joints altogether. The mean follow up time was 11,2 years

Results: In the SF-36 score, the mean physical component scale (PCS) was worse (37,2 vs 41,7, p=0,004), the mean mental component scale (MCS) better (52,3 vs 50,3, p=0,092) than normative values of a German population. Subjective assessment by the PREE revealed a mean of 66,8, by the mASES of 63,1 and by the DASH of 56,5 points. Clinical examination resulted in a mean mASES score of 71,6 points. Comparison between the patients self assessment and the objective score revealed a significant correlation between the DASH (r=0,46, p< 0,001), PREE (p=0,54, p< 0,001) and mASES (r=0,60, p< 0,001) with the clinical mASES. In contrast, no significant correlation was found between the physical component scale (PCS) and mental component scale (MCS) of SF-36 and the clinical mASES. Also the patients assessment scores DASH, PREE and mASES showed a strong significant correlation among one another (r=0,74–0,92, p< 0,001) and (PCS) (r=0,58–0,75, p< 0,001) but not with the (MCS) of SF-36.

Conclusion: Assessment of long term results after elbow arthroplasty yielded favourable clinical and subjective results. The clinical outcome tended to be higher than results of the patient self-rated scores. Hereby, the newly developed assessment set proved to be a feasible tool for a comprehensive assessment of elbow function. In addition to clinical outcome assessment, with this set it is possible to gain important and new insights on the relationship between objective measures and subjective patients-assessment of elbow disorders and postoperative conditions.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 135 - 135
1 Mar 2006
Flury M Siebertz D Goldhahn J Schwyzer H Simmen B
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Introduction Shoulder prosthesis of the third generation should allow a better restoration of the center of rotation in the replaced humeral head and a better adaptation to anatomical complex situations. Finally this should lead to an improved functional outcome compared with common types of prosthesis. We performed a retrospective study using the far most accepted scores to assess functional outcome and quality of lifer in order to compare our results with the clinical literature.

Materials and Methods 107 patients with a total of 111 prosthesis out of 127 patients were evaluated 3 to 4 years after implantation of a cemented prosthesis of the third generation (Aequalis″< caron> ) combined with a pegged Glenoid. The functional outcome was evaluated with the following scores: DASH, ASES, SPADI and Constant score (CS). Quality of life was rated using short form 36 (SF-36). Further data were recorded using a comorbidity self-assessment, a sociodemographic and a transition questionnaire. Patient data from SF-36, DASH and Constant Score were compared with normative data from age-, sex- and comorbidity corrected control groups. Paired, non-parametric testing was performed with the Wilcoxon-Test and Bonferroni correction. Radiographs were taken in three standard planes and the glenoid was evaluated according to Lazarus et al.

Results The Constant score at the time of follow up reached with 72±16 97% of the norm population. The subscore pain improved in average from 3 to 12 (maximum 15) and the subscore mobility from 14 to 32 (maximum 40).

Patients with primary arthrosis (n=44) and patients with posttraumatic arthrosis (n=39) had no functional deficits compared to the normal population in contrast to patients with RA (n=17). They showed significantly functional deficits (p< 0.001) in the DASH score as well as in the physical sum scale of the SF-36 (p=0.008). The majority of glenoids showed an incomplete lyses around one dowel (grade I in 70%). Less than 2% showed grade III or IV.

Discussion Implantation of a shoulder prosthesis of the third generation leads to good functional results compared with the control population. Functional and physical deficits remain in patients with an underlying RA. Glenoid loosening seems to be of minor concern. Our results prove the good clinical results that are reported in the literature, however they have to be proven with a longer follow-up.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 134 - 134
1 Mar 2006
Spormann C Simmen B
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Introduction: The design of the GSB III elbow arthroplasty has essentially remained unchanged since 1978 until recently. Because of observations of aseptic loosening of the ulnar component, the ulnar stem was changed in an excentric curved shape. The aim of the present study was to assess the clinical and radiographic outcome after more than 2 years of follow up with the new ulnar stem shape.

Patients and methods: Between january 2000 and august 2002, 34 patients had undergone 36 total elbow replacements with the GSB III device with a new curved ulnar shape. Nineteen patients (20 elbows) underwent the operation for the first elbow arthroplasty and 16 patients underwent revision surgery. The mean follow up was 35 months (R: 25–49). The subjective satisfaction and pain intensity were assessed. Clinical exam recorded range of motion and strength. Radiographs were analysed for implant loosening and osteolysis.

Results: There was a significant improvement of the average range of motion in flexion-extension from pre-operative 82degree to postoperative 105degree for all 36 elbows (t-test, p< 0,005). The 20 cases with primary elbow arthroplasty showed a significant improvement in the average range of flexion-extension from 76degree to 106degree (t-test, p< 0,001). The subjective assessment for satisfaction averaged 93 per cent at the time of follow up. For the 16 patients with revision elbow arthroplasty, the average range of flexion-extension improved from 90degree to 103degree (p< 0,01). The mean subjective satisfaction rated at 94 per cent. One case showed a radiolucent line at the ulnar component which remained unchanged at follow up. There was no component loosening.

Discussion: The new excentric curved ulnar component shows no case of component loosening in our series for primary and revision elbow arthroplasty after 2 years. The range of motion and patient satisfaction are promising.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_I | Pages 4 - 4
1 Jan 2004
Langlotz F Herren D Simmen B Baumgartner W
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Correct placement of the total elbow endoprosthesis is a critical factor for the long-term success of an artificial joint. Correct restoration of the centre of rotation is essential for optimal outcome. To evaluate whether surgical navigation has the potential to improve accuracy during Total Elbow Arthroplasty (TEA), an existing CAS system was applied on one plastic model and three patients.

The spine module of the SurgiGATE™ navigation system (Medivision, Oberdorf, Switzerland) was used. To apply it during TEA, a standard 3.5-mm drill guide was instrumented with infrared LEDs and calibrated. A dynamic reference base (DRB) was developed. Its base consisted of an X-shaped, scissors-like construct that could be clamped rigidly onto the distal humerus after exposure. On a plastic model, the DRB design was evaluated, and three landmarks suitable for intraoperative matching were identified. Subsequently, the Spine system was applied during three TEA surgeries. For the first surgery no pre-operative CT scan was acquired, but the design of the DRB, its camera visibility, and the accessibility of the landmarks were verified. For the other cases, the elbows were CT-scanned preoperatively. Planning consisted of 3-D segmentation as well as the definition of matching landmarks and a trajectory representing the position of a Steinmann pin, with which the humeral implant position is defined. Intraoperatively, the DRB was fixated, and matching was performed. Using the navigation system, the drill guide could then be aligned with the planned trajectory.

For the second patient, no accurate matching was achieved, hence surgery was completed conventionally. The last patient could be registered precisely, and the Steinmann pin was placed as planned.

Preliminary results show that CT-based navigation can be applied during TEA. Given a positive output of an ongoing clinical study, the development of a special TEA navigation system is planned.