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

• Sponsor: Technische Universität Dresden (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05952622
• Collaborator: (none)
• Enrollment: 103
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 69
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Proximal Humerus Fracture	Device: Continuous passive motion therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 therapyPatients 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.
• Primary Purpose: Treatment
• Official Title: Comparison of Functional and Patient-reported Outcome Using Continuous Passive Motion in Rehabilitation After Plate Osteosynthesis of Proximal Humerus Fractures
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: Feb 28, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year [Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment]

   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°

2. Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year [Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment]

   Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100

3. Change of Constant-Score (CSS) after 6 weeks, 12 weeks and 1 year [Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment]

   Evaluation of the subjective function (patient reported outcome) using the Constant-Score, 0-100, best: 100, worst: 0

4. Change of Pain on visual analogue scale (VAS) after 6 weeks, 12 weeks and 1 year [Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment]

   Evaluation of the subjective pain using a visual analogue scale, 0-10, best:0, worst: 10

5. Change of Subjective satisfaction with surgical treatment (SSV) after 6 weeks, 12 weeks and 1 year [Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment]

   Evaluation of the subjective satisfaction using the subjective shoulder value, 0-100, best:100, worst: 0

Secondary Outcome Measures

1. Influence of demographic factors upon rehabilitation process [Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment]

   Evaluation of the underlying demographic factors (gender, age, BMI) and whether these affect the functional and patient-reported outcome (univariate regressional analysis)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden	Dresden	Saxonia	Germany	01307

Sponsors and Collaborators

• Technische Universität Dresden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Technische Universität Dresden
• ClinicalTrials.gov Identifier: NCT05952622
• Other Study ID Numbers: CPM
• First Posted: Jul 19, 2023
• Last Update Posted: Jul 19, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Technische Universität Dresden: proximal humerus fracture; plate osteosynthesis; rehabilitation; continuous passive motion
• Additional relevant MeSH terms: Fractures, Bone; Humeral Fractures

Study Results

No Results Posted as of Jul 19, 2023