Smartphone Application to Help Rehabilitation After Palmar Plate Osteosynthesis of Distal Radius Fracture

Sponsor

Hôpital Fribourgeois (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06005857

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate of the effectiveness of a Smartphone application in aiding post-operative rehabilitation of an intra-articular distal radius (wrist) fracture.

This study will focus on healthy patients operated on for isolated wrist fractures (intra articular fracture of the distal radius with or without fracture of the distal ulna/cubitus) using plate and screw.

The PhysiApp application is a secure smartphone application that enables therapists to transmit personalized rehabilitation exercises to patients. Its effectiveness in patients undergoing surgery for intra-articular fractures of the distal radius fracture.

The aim of our research project is to determine the effectiveness of this application for patients undergoing intra-articular distal radius fracture surgery at the Cantonal Hospital of Fribourg in Switzerland.

The operation itself will be carried out in the usual way. However, rehabilitation will be carried out with the help of the application, in addition to the usual follow-up by a hand therapist.

The aim is to improve wrist mobility and function.

Once wrist surgery has been performed (plate and screw osteosynthesis), post-operative rehabilitation will either take place in the company of a hand therapist, using the smartphone application, or will consist solely of conventional rehabilitation by a hand therapist only.

Only the patient and the therapist will be aware of the use of the application. The follow-up doctor will receive no information on the treatment methods (single-blind procedure), to enhance the scientific quality of the results of this study.

During the 3 months following the operation, wrist mobility will be measured and questionnaires on wrist function will be completed by patients.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture	Other: Standard hand therapy program + smartphone application Other: Standard hand therapy program	N/A

Detailed Description

The smartphone application (PhysiApp) will be analyzed for patients undergoing intra articular distal radius fracture treated by open reduction and internal fixation by palmar plate.

Primary endpoint: range of motion. Secondary endpoints: clinical scores (PRWE and Cooney score), visual analogue scale (VAS), grip strength and patient's satisfaction.

Inclusion criteria :

Complete intra-articular DRF (classification AO 23 C1, C2 or C3)
Simple palmar operative approach
Simple palmar pate fixation
DRUJ instability with ulnar styloid fixation needed
Age 18-65 years
French or German speaker

Exclusion criteria :

Extra-articular or partial-articular DRF
Double/triple operative approaches needed
Bilateral procedure
Fracture aged than more of 2 weeks
Patient refusal/no informed consent
Inability to give informed consent
Previous wrist injury or surgery
Pregnant women
Rheumatoid polyarthritis
Body mass index > 40kg/m2
Refusal to be informed of an incidental finding that has a direct impact on health status

All patients will undergo the same operative procedure. Upon arrival to the operating room, patients will be placed in supine position, the injured limb resting on a hand table. Standard anesthetic axillary nerve will be applied. All the operation will do by an experienced hand surgeon having minimum 5 years of post-specialization clinical experience. A standard modified Henry approach will be done. The DRF will be reduced and fixed with a palmar plate (Aptus Adaptive II, Medartis®). The stability of the distal radio ulnar joint (DRUJ) will be tested after the radius fixation. If the DRUJ will be instable, the ulnar styloid fracture will be fixed (osteo suture (PDS wire) or screw fixation (Aptus CCS 1.7/2.2, Medartis®)).

Patients will be recruited from the emergency department. After the operation, whether the criteria are met and their consent obtained, patients will be announced to an independent study coordinator who is responsible for allocation consignment.

The investigator will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail. Each participant will be informed that the participation in the study is voluntary and that he or she may withdraw from the study at any time, and that withdrawal of consent will not affect his or her subsequent medical assistance and treatment.

The participant will be informed that his or her medical records may be examined by authorised individuals other than their treating physician. These medical records may also be used for further research.

All participants in the study will receive a participant information sheet and a consent form describing the study and providing sufficient information for the participants to make an informed decision about their participation in the study. They will have the opportunity to ask questions.

The formal consent of a participant, using the approved consent form, will be obtained before the participant is submitted to any study procedure.

The consent form will be signed and dated by the investigator or his designee at the same time as the participant signs. A copy of the signed informed consent will be given to the study participant. The consent form will be retained as part of the study records.

Two to three days after surgery, participants will be addressed by the study hand therapist. This therapist will randomly assign the participants by drawing lots from a sealed envelope containing the study group.

All patients will undergo the same postoperative splint immobilization (removable palmar custom splint) for 6 weeks.

Patients will be randomly assigned to receive either the test item (standard hand therapy program + smartphone application) or a standard hand therapy program.

The unblinded study hand therapist will realize the removable palmar custom splint and do the rehabilitation of all patients of the 2 groups during 12 weeks. At 6, 9 and 12 weeks, the hand therapist will apply the standard post operative hand rehabilitation protocol and will measure ROM, clinical scores, and monitor possible adverse events.

At 6, 9 and 12 post-operative weeks, the unblinded study hand therapist will realize photos of the wrist (flexion, extension, pronation and supination). These photos will be analyzed and ROM will be measure by a blinded investigator.

At 45 and 90 days, the blinded surgeon (not aware of the therapy the patient is undergoing) will research any clinical or radiological adverse events.

The smartphone application used is "PhysiApp". This application has been selected because it ensures a high level of data protection. Professional videos demonstrating the required exercises will be prepared by the communication department of the HFR Fribourg - Hôpital cantonal, under the supervision of the study hand therapist. Patients in the group using the application will install the latter on their personal phone and thus have access to the exercises program. Patients will be able to manage notification alarms themselves.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Validation of a Smartphone Application to Enhance Hand Therapy Adherence of Patient After Palmar Plate Osteosynthesis of Distal Intra Articular Radius Fracture: A Multidisciplinary Prospective Randomized Simple-blind Controlled Trial

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group standard hand therapy program + smartphone application A group receive either the test item (standard hand therapy program + smartphone application).	Other: Standard hand therapy program + smartphone application Standard post-operative hand rehabilitation and using the smartphone application
Active Comparator: Group intervention and group control The control group will receive a standard hand therapy program.	Other: Standard hand therapy program Standard post-operative hand rehabilitation alone

Arm

Intervention/Treatment

Experimental: Group standard hand therapy program + smartphone application

A group receive either the test item (standard hand therapy program + smartphone application).

Other: Standard hand therapy program + smartphone application

Standard post-operative hand rehabilitation and using the smartphone application

Active Comparator: Group intervention and group control

The control group will receive a standard hand therapy program.

Other: Standard hand therapy program

Standard post-operative hand rehabilitation alone

Outcome Measures

Primary Outcome Measures

Range of motion [From enrollment to the end of treatment at 3 months]
Measurement (in degrees) of joint mobility using a goniometer

Secondary Outcome Measures

Clinical outcomes [From enrollment to the end of treatment at 3 months]
Clinical score (Patient-Rated Wrist Evaluation) at 6 , 9 and 12 weeks after surgery. The Patient-Rated Wrist Evaluation score measure the pain score of all 5 items, measure the function score of all the 10 items. The total score the sum of pain and function scores. The best score is 0 and the worst score is 100.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Complete intra-articular DRF (classification AO 23 C1, C2 or C3)
Simple palmar operative approach
Simple palmar pate fixation
DRUJ instability with ulnar styloid fixation needed
Age 18-65 years
French or German speaker

Exclusion Criteria:

Extra-articular or partial-articular DRF
Double/triple operative approaches needed
Bilateral procedure
Fracture aged than more of 2 weeks
Patient refusal/no informed consent
Inability to give informed consent
Previous wrist injury or surgery
Pregnant women
Rheumatoid polyarthritis
Body mass index > 40kg/m2
Refusal to be informed of an incidental finding that has a direct impact on health status