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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Proximal Humerus Fracture
• Intervention / Treatment: Device: Continuous passive motion therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxonia
    • Dresden, Saxonia, Germany, 01307
      • University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard rehabilitation protocol; Standard rehabilitation after surgical treatment consisting of initial immobilization followed by physiotherapy.
Active Comparator: Rehabilitation protocol with CPM; Additional treatment of patients with continuous passive motion after initial immobilization for 6 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): February 28, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; continuous passive motion; proximal humerus fracture; plate osteosynthesis
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: CPM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No