Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy

Proximal Humerus Fracture Clinical Trial

Official title:

Comparison of Functional and Patient-reported Outcome Using Continuous Passive Motion in Rehabilitation After Plate Osteosynthesis of Proximal Humerus Fractures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05952622
• Other study ID #: CPM
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients suffering from a proximal humerus fracture treated with plate osteosynthesis will receive either regular aftercare (physiotherapy) or aftercare assisted with continous passive motion (physiotherapy + CPM). Change in functional and patient-reported outcome (PROM) over time will be evaluated and compared.

Description:

The investigators will conduct a prospective, monocentric study focusing on the rehabilitation process after surgical treatment of proximal humerus fractures. Patients treated with plate osteosynthesis and eligible to participate will be randomly assigend to either a regular rehabilitation protocol (immobilization and physiotherapy) or a rehabilitation protocol with the additional use of a continous passive motion device (immobilization, physiotherapy and CPM). After 6 and 12 weeks as well as 1 year in a follow-up examination functional (range of motion) and patient-reported outcome (Disabilities of Arm, Shoulder and Hand Score [DASH], Constant-Score, pain on visual analogue scale, subjective satisfaction) will be evaluated. Results will be compared towards possible differences and effect of CPM therapy. In addition demographic factors (age, sex, BMI, etc.) and complications will be analysed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: December 31, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with proximal humeral fracture treated with plate osteosynthesis during the enrollment period
• understanding of German language (written and oral)
• written informed consent of the patient or the legal guardian

Exclusion Criteria:

• patients not meeting the aforementioned criteria
• patients with the need of / or an already existing endoprosthesis
• patients with ipsilateral fracture of the distal radius
• patients with cerebral damage (contusio or commotio cerebri)
• patients with affection of the brachial plexus or nerve palsy
• non-compliance

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humerus Fracture

Intervention

Device:
• Continuous passive motion therapy
Patients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks.

Locations

Country	Name	City	State
Germany	University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden	Dresden	Saxonia

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year	Objetive functional clinical result. Evaluation ot Motion of the shoulder in ° measured via goniometer. Physiological Abduction/Adduction: 180/0/40°, Anteversion/Retroversion 160/0/40°, external/internal rotation: 70/0/60°	Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Primary	Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year	Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100	Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Primary	Change of Constant-Score (CSS) after 6 weeks, 12 weeks and 1 year	Evaluation of the subjective function (patient reported outcome) using the Constant-Score, 0-100, best: 100, worst: 0	Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Primary	Change of Pain on visual analogue scale (VAS) after 6 weeks, 12 weeks and 1 year	Evaluation of the subjective pain using a visual analogue scale, 0-10, best:0, worst: 10	Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Primary	Change of Subjective satisfaction with surgical treatment (SSV) after 6 weeks, 12 weeks and 1 year	Evaluation of the subjective satisfaction using the subjective shoulder value, 0-100, best:100, worst: 0	Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Secondary	Influence of demographic factors upon rehabilitation process	Evaluation of the underlying demographic factors (gender, age, BMI) and whether these affect the functional and patient-reported outcome (univariate regressional analysis)	Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment