Research study comparing the effectiveness of a new device used for a type of wrist fractures

Non-randomized controlled trial on the stability and outcome of the conventional wrist-spanning external fixator versus an invented low cost wrist-spanning radio-metacarpal external fixator for comminuted displaced distal radius fractures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2017/009

Enrollment

Unknown

Registered

2017-03-28

Start date

2018-02-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fractures

Interventions

Study setting: Designated Orthopaedic Unit (Dr. R. Sooriyarachchi, Consultant Orthopaedic Surgeon), National Hospital of Sri Lanka. Experimental / Study group: Patients admitting with severely commin

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or above 2. Severely comminuted and displaced distal radius fractures (diagnosed by AP + lateral x-ray)

Exclusion criteria

Exclusion criteria: 1. Skeletally immature patients where age is less than 18 years

Design outcomes

Primary

Measure	Time frame
Presence of pain at wrist with movement while on external fixator (assessed using a 5 point scale) [At week 1,4,6 and 12 post-operatively] Presence of pin-site infections – Grade 4,5,6 (Checketts–Otterburn classification [At week 1,4,6 and 12 post-operatively] Presence of significant wrist joint stiffness with reduced range of movement by 50% or more (0) on clinical examination [At week 1,4,6 and 12 post-operatively ] Radial height being less than 2mm (radiological examination) [At week 1,4,6 and 12 post-operatively ] Radial length being less than 8mm (radiological examination) [At week 1,4,6 and 12 post-operatively ] Radial inclination being less than 100 (radiological examination) [At week 1,4,6 and 12 post-operatively ] Negative value for volar tilt (on radiological examination) [At week 1,4,6 and 12 post-operatively ] Intra-articular step more than 2mm (radiological examination) [At week 1,4,6 and 12 post-operatively ]	—

Measure

Time frame

Presence of pain at wrist with movement while on external fixator (assessed using a 5 point scale) [At week 1,4,6 and 12 post-operatively] Presence of pin-site infections – Grade 4,5,6 (Checketts–Otterburn classification [At week 1,4,6 and 12 post-operatively] Presence of significant wrist joint stiffness with reduced range of movement by 50% or more (0) on clinical examination [At week 1,4,6 and 12 post-operatively ] Radial height being less than 2mm (radiological examination) [At week 1,4,6 and 12 post-operatively ] Radial length being less than 8mm (radiological examination) [At week 1,4,6 and 12 post-operatively ] Radial inclination being less than 100 (radiological examination) [At week 1,4,6 and 12 post-operatively ] Negative value for volar tilt (on radiological examination) [At week 1,4,6 and 12 post-operatively ] Intra-articular step more than 2mm (radiological examination) [At week 1,4,6 and 12 post-operatively ]

—

Secondary

Measure	Time frame
None [None]	—

Countries

Sri Lanka

Contacts

Public ContactG.A.L. Niroshana

Registrar in Orthopedic Surgery

lamindu@yahoo.comTel: 0112-691111

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Research study comparing the effectiveness of a new device used for a type of wrist fractures

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Outcome results