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

NCT05952622 | Unknown

• 1 other identifier: CPM
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Humerus Fracture

Keywords

proximal humerus fracture; plate osteosynthesis; rehabilitation; continuous passive motion

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Influence of demographic factors upon rehabilitation process

  Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment

Study Arms (2)

Standard rehabilitation protocol

NO INTERVENTION

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

Rehabilitation protocol with CPM

ACTIVE COMPARATOR

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

Device: Continuous passive motion therapy

Interventions

Continuous passive motion therapy DEVICE

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

Rehabilitation protocol with CPM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

• Tille E, Lorenz F, Beyer F, Schlussler A, Biewener A, Nowotny J. Early functional improvements using continuous passive motion therapy after angular-stable plate osteosynthesis of proximal humerus fractures - results of a prospective, randomized trial. J Orthop Surg Res. 2024 May 28;19(1):313. doi: 10.1186/s13018-024-04804-x.

  PMID: 38802866 DERIVED

MeSH Terms

Interventions

Motion Therapy, Continuous Passive

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients are randomly assigend, masking is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: July 19, 2023
• Study Start: April 1, 2018
• Primary Completion: February 28, 2022
• Study Completion: December 31, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)