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Outcome analysis in the conservative therapy of a radius fracture with OptivoHand/plaster

Outcome analysis in the conservative therapy of a radius fracture with OptivoHand/plaster - OPTIVO II

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017695
Enrollment
50
Registered
2019-11-04
Start date
2020-05-31
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S52.5

Interventions

Group 1: After the reduction of the fracture, the OptivoHand splint is applied to the patient. The patient wears this splint until the end of treatment. Group 2: After the reduction of the fracture, t

Sponsors

BG Unfallklinik Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: distal radial fracture AO 23-A2, A3, B1, B2, B3, C2, C3, no soft tissue damage, non-operative treatment, patients must be able to support non-operative treatment

Exclusion criteria

Exclusion criteria: • surgery • deformity of the wrist • loss of sensibility or decrease of sensibility of the hand • neurodegenerative diseases incl. dementia • tumors/pathological fractures • Other fractures and concomitant injuries • age <18 years • Lack of compliance or patients who are unable to support conservative treatment.

Design outcomes

Primary

MeasureTime frame
The first primary objective of the study is to preserve the reduction result by the Optivo hand in comparison to the previous standard treatment with a split forearm cast in the radiological control after reduction and application of the orthesis or cast.

Secondary

MeasureTime frame
Secondary endpoints are patient satisfaction post-operatively measured on the SF-36 questionnaire and the DASH score. The functional outcome, the mobility of the hand according to the Neutral-0 method and the duration of incapacity for work were also assessed. The patients are examined in 1,2,6 weeks and after 3 and 12 months after reduction.

Countries

Germany

Contacts

Public ContactPhilipp Hemmann

Berufsgenossenschaftliche Unfallklinik Tübingen

phemmann@bgu-tuebingen.de004970716063158

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026