Multicentre observational study for the treatment of osteoarthritis of the thumb using Actimove® Rhizo Forte

Multicentre observational study for the treatment of osteoarthritis of the thumb using Actimove® Rhizo Forte

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The Actimove Rhizo Forte thumb orthosis is suitable for the treatment of painful osteoarthritis (OA) of the thumb of the saddle joint. The shape of the orthosis allows free movement of the adjacent hand and finger joints, while enabling secure immobilisation of the saddle joint. Due to the integrated aluminium core, the orthosis can be individually adjusted to different hand shapes.

 

A multicentre, prospective, post-market observational study for the treatment of osteoarthritis (OA) of the thumb is summarised as:1

 

Aim

Subsequent to the development of the orthosis, a prospective, open observational study was performed in three orthopaedic study centres in Germany. The aim of the study was to evaluate the product, particularly with regard to the fit of the orthosis, comfort and suitability for daily use, as well as the medical parameters’ effectiveness and safety under the conditions of routine practice in a standardised way.

 

Method

Patients: 28 patients (78.6% females, 59.5 ± 10.7 years on average) with a radiologically confirmed diagnosis of OA of the thumb were included into the observational study.

Treatment: The application of the Actimove Rhizo Forte thumb orthosis followed the manufacturer’s recommendations and clinical requirements. The duration of the wearing period depended on the individual complaints and was 7 weeks on average (range 2.8 to 10 weeks) for 8 hours a day (range 4.4 to 10.5 hours). Study procedures were specified in a study protocol. At the initial and the final visit, the Actimove Rhizo Forte thumb orthosis was evaluated with regard to general requirements (handling, fit, comfort, opening and closing, shape system, suitability for daily use, patient satisfaction, overall evaluation) and medical requirements (occurrence of pressure points, localisation of pressure points on the palm and back of the hands, moisture, and sweating) independently by the patients and the treating specialist in orthopaedics.

 

Results

Evaluation of general requirements: The majority of patients and treating physicians assessed the orthosis as “good” to “very good”. Particularly, handling and opening and closing of the orthosis was assessed as “very good”. Patients evaluated comfort as “good” and suitability for daily use as “rather good” after wearing the orthosis over several weeks. Overall, the patients and the treating physician were very satisfied with the orthosis. There were no differences between the assessments before and after treatment, except with the parameter “handling”: assessment of “handling” increased from “good” to “very good” at the end of the observational study.

 

Conclusions

The results of this observational study of 28 patients with clinically confirmed OA of the thumb demonstrate that the use of Actimove Rhizo Forte thumb orthosis led to a considerable pain reduction through secure immobilisation. Moreover, easy handling, easy opening and closing of the orthosis and comfort was rated highly by the patients. Pressure points at the palms and backs of the hands were observed in a minority of patients, but, generally, cannot be fully excluded due to the specific material and type of construction of the orthosis. Therefore, the Actimove Rhizo Forte thumb orthosis has demonstrated its ability for conservative treatment of the OA of the thumb and may add important value to the existing therapy options.

For further information regarding the Actimove Rhizo Forte, please contact your Essity Account Manager or the Concierge Team on Concierge.Service@essity.com . Alternatively click on the link to read more Actimove® Rhizo Forte – PROFESSIONAL LINE (essity.co.uk)

 

References

1) Möller J, Pfeil U, Weinhardt C, report to BSN medical 2015, data on file.

2) Ladd AL, Weiss AP, Crisco JJ, Hagert E, Wolf JM, Glickel SZ, Yao J. The thumb carpometacarpal joint: anatomy, hormones, and biomechanics. Instr Course Lect. 2013;62:165-79.

 

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