Nonoperative Treatment of Dorsally Dislocated Distal Radius Fractures in Adults With an Individualized 3D Printed Brace.

NCT ID: NCT03848702

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-07-01

Brief Summary

Study design: Two consecutive prospective case series. Study population: Part 1 will enroll 10 healthy volunteers (50 years or older). Part 2 will enroll 10 elderly patients (50 years or older) with a dorsally displaced distal radius fracture (AO type 23-A-C) that is acceptably reduced. In both parts, participants should have no restrictions in activities of daily living pre-fracture and no evident anatomical difference between both wrists.

Intervention:

Part 1: Participants will wear the brace continuously for one week. Part 2: Participants will wear the brace as treatment of the fracture for five weeks (instead of a plaster cast).

Main study parameters/endpoints: In parts 1 and 2, the primary outcome measure will be a Visual Analog Scale (VAS) score for wearing comfort. Secondary outcome measures are the occurrence of fracture redislocation (part 2 only), pain (VAS), inconvenience during NL61002.078.17 / DRFB-Tolerability Distal Radius Fracture Brace Tolerability Version number: 1.1, d.d. April 24, 2017 8 of 34 activities of daily living (Katz Index), and adverse reactions like pain, skin pressure, skin irritation/redness, sensibility issues, or device-related problems.

Detailed Description

Rationale: Each year, approximately 34,500 adults in The Netherlands sustain a fracture of the distal radius (wrist fracture). Incidence peaks in the elderly. The currently preferred treatment is closed reduction and nonoperative treatment by immobilization in a plaster cast for 4-6 weeks. Surgery is only performed if closed reduction fails or redislocation occurs. Plaster immobilization is inconvenient and interferes with daily activities. More importantly, standard nonoperative treatment often fails; in 40-60% of the fractures, redislocation requires surgery. Surgical treatment is about 9 times more expensive than nonoperative treatment and not without risks. This project aims to develop an innovative nonoperative treatment option. The central idea is to produce a 3D-printed brace for the fractured wrist using a mirrored CT-scan of the contralateral, unfractured wrist as a model. This innovative approach has the advantage that it does not depend on surgery and provides a better and potentially more durable positioning than the currently applied plaster cast. We expect that redislocation will occur less frequently, so surgery may be avoided. In contrast to a traditional plaster cast, the newly developed brace is water resistant/repellant, lighter, and enables movement of the hand. It enables daily activities and improves independency in the elderly with a wrist fracture. The treatment has been successfully evaluated in an ex vivo model. The clinical implementation will follow a step-wise approach.

Objective: Part 1 aims to determine the tolerability of the 3D-printed brace when worn by healthy volunteers (50 years of order), performing their normal daily activities. In part 2, the objective is to determine tolerability of the 3D-printed brace in patients (50 years or older) with an extra-articular distal radius fracture with dorsal displacement, performing their normal daily activities.

Conditions

Dorsal Displacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Healthy volunteers

All volunteers wore the DRFB

Group Type: EXPERIMENTAL

Distal radius fracture brace

Intervention Type: DEVICE

The distal radius fracture brace is constructed from biocompatible materials (like polylactic acid; PLA) and the skin is protected by commercially available and approved waterproof padding (like Aquacast®). The major brace components are connected and reinforced with carbon rods and plastic bolt-nut connections. PLA is extensively used, for example in surgical implants, but also as biological alternative for plastics. Aquacast® is approved and used as waterproof padding in swim plaster. The biomechanical function of the distal radius brace has been tested successfully in an ex vivo setting (results to be published). The DRFB includes the distal forearm, wrist an base of the hand. The thumb and fingers are free and the DRFB provides more movement than classical casting.

Patients with DRF

All patients wore the DRFB

Group Type: EXPERIMENTAL

Distal radius fracture brace

Intervention Type: DEVICE

The distal radius fracture brace is constructed from biocompatible materials (like polylactic acid; PLA) and the skin is protected by commercially available and approved waterproof padding (like Aquacast®). The major brace components are connected and reinforced with carbon rods and plastic bolt-nut connections. PLA is extensively used, for example in surgical implants, but also as biological alternative for plastics. Aquacast® is approved and used as waterproof padding in swim plaster. The biomechanical function of the distal radius brace has been tested successfully in an ex vivo setting (results to be published). The DRFB includes the distal forearm, wrist an base of the hand. The thumb and fingers are free and the DRFB provides more movement than classical casting.

Interventions

Distal radius fracture brace

The distal radius fracture brace is constructed from biocompatible materials (like polylactic acid; PLA) and the skin is protected by commercially available and approved waterproof padding (like Aquacast®). The major brace components are connected and reinforced with carbon rods and plastic bolt-nut connections. PLA is extensively used, for example in surgical implants, but also as biological alternative for plastics. Aquacast® is approved and used as waterproof padding in swim plaster. The biomechanical function of the distal radius brace has been tested successfully in an ex vivo setting (results to be published). The DRFB includes the distal forearm, wrist an base of the hand. The thumb and fingers are free and the DRFB provides more movement than classical casting.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Part 1:

1. Age 50 years or older

2. Healthy volunteer without distal radius fracture

3. No restrictions in activities of daily living prior to enrolment*

4. Signed informed consent by participant * Participant should exercises complete self-control over urination and defecation, but use of incontinence material is allowed.

Part 2:

1. Patients (50 years or older) with an acute**, unilateral distal radius fracture with dorsal displacement (AO type 23-A, B, or C) that is acceptably reduced (by simple closed reduction with vertical longitudinal traction)

2. No restrictions in activities of daily living pre-fracture*

3. Signed informed consent by patient

• Participant should exercises complete self-control over urination and defecation, but use of incontinence material is allowed. ** Patients should report to the Emergency Department within 48h post-trauma.

Exclusion Criteria

Part 1:

1. Preexisting anatomical deviation of the ipsi- or contralateral wrist

2. Conditions that affect function of the wrist or hand

3. Insufficient comprehension of the Dutch or language to understand the study documents

4. Participant unwilling or unable to comply with the study protocol and follow-up visit schedule

5. Known allergy for brace material (PLA or alternative)

Part 2:

1. Preexisting anatomical deviation of the ipsi- or contralateral wrist

2. Additional traumatic injuries that affect treatment, rehabilitation, or function of the affected hand

3. Pathological, recurrent, or open fracture

4. Impaired wrist function pre-trauma at either wrist (e.g., arthrosis, rheumatoid disorder, or neurological disorder)

5. Bone disorder that may impair bone healing, excluding osteoporosis

6. Patient unwilling or unable to comply with the treatment protocol and follow-up visit schedule

7. Insufficient comprehension of the Dutch language to understand the study documents

8. Known allergy for brace material (PLA or alternative).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

VieCuri Medical Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VieCuri MC

Venlo, Limburg, Netherlands

Countries

Netherlands

References

Janzing HMJ, Bessems SAM, Ligthart MAP, Van Lieshout EMM, Theeuwes HP, Barten DG, Verhofstad MHJ. Treatment of dorsally dislocated distal radius fractures with individualized 3D printed bracing: an exploratory study. 3D Print Med. 2020 Aug 18;6(1):22. doi: 10.1186/s41205-020-00075-4.

Reference Type: DERIVED

PMID: 32809083 (View on PubMed)

Other Identifiers

Nl61002.078.17

Identifier Type: -

Identifier Source: org_study_id