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

Primary Purpose

Proximal Humerus Fracture

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Continuous passive motion therapy
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humerus Fracture focused on measuring proximal humerus fracture, plate osteosynthesis, rehabilitation, continuous passive motion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard rehabilitation protocol

Rehabilitation protocol with CPM

Arm Description

Standard rehabilitation after surgical treatment consisting of initial immobilization followed by physiotherapy.

Additional treatment of patients with continuous passive motion after initial immobilization for 6 weeks.

Outcomes

Primary Outcome Measures

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°
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
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
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
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

Secondary Outcome Measures

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)

Full Information

First Posted
April 19, 2023
Last Updated
July 17, 2023
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT05952622
Brief Title
Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy
Official Title
Comparison of Functional and Patient-reported Outcome Using Continuous Passive Motion in Rehabilitation After Plate Osteosynthesis of Proximal Humerus Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humerus Fracture
Keywords
proximal humerus fracture, plate osteosynthesis, rehabilitation, continuous passive motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are assigned to one of two rehabilitation protocols consisting of either A: initial immobilization followed by physiotherapy or B: initial immobilization followed by physiotherapy and additional continuous passive motion therapy
Masking
None (Open Label)
Masking Description
Patients are randomly assigend, masking is not possible.
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard rehabilitation protocol
Arm Type
No Intervention
Arm Description
Standard rehabilitation after surgical treatment consisting of initial immobilization followed by physiotherapy.
Arm Title
Rehabilitation protocol with CPM
Arm Type
Active Comparator
Arm Description
Additional treatment of patients with continuous passive motion after initial immobilization for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Continuous passive motion therapy
Intervention Description
Patients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks.
Primary Outcome Measure Information:
Title
Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year
Description
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 Frame
Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Title
Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year
Description
Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100
Time Frame
Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Title
Change of Constant-Score (CSS) after 6 weeks, 12 weeks and 1 year
Description
Evaluation of the subjective function (patient reported outcome) using the Constant-Score, 0-100, best: 100, worst: 0
Time Frame
Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Title
Change of Pain on visual analogue scale (VAS) after 6 weeks, 12 weeks and 1 year
Description
Evaluation of the subjective pain using a visual analogue scale, 0-10, best:0, worst: 10
Time Frame
Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Title
Change of Subjective satisfaction with surgical treatment (SSV) after 6 weeks, 12 weeks and 1 year
Description
Evaluation of the subjective satisfaction using the subjective shoulder value, 0-100, best:100, worst: 0
Time Frame
Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Secondary Outcome Measure Information:
Title
Influence of demographic factors upon rehabilitation process
Description
Evaluation of the underlying demographic factors (gender, age, BMI) and whether these affect the functional and patient-reported outcome (univariate regressional analysis)
Time Frame
Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
City
Dresden
State/Province
Saxonia
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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