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Comparison of Single-Tunnel Unidirectional Coracoclavicular Loop Stabilization versus Hook Plate Fixation for Unstable Distal Clavicle Fractures: A Prospective Randomized Controlled Trial

Comparison of Single-Tunnel Unidirectional Coracoclavicular Loop Stabilization versus Hook Plate Fixation for Unstable Distal Clavicle Fractures: A Prospective Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260625003
Enrollment
40
Registered
2026-06-25
Start date
2025-06-05
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

Patients with unstable distal clavicle fractures Distal clavicle fracture

Interventions

Patients in the intervention group underwent single-tunnel unidirectional coracoclavicular loop stabilization. An Endobutton (Smith &amp
Nephew) loaded with Ultratape (Smith &amp
Nephew) was then introduced to single-tunnel of clavicle. Ultratape was passed beneath the coracoid process. The free limbs of the Ultratape were then passed through the Endobutton, creating a four-
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Single-Tunnel Unidirectional Coracoclavicular Loop Stabilization ,hook plate fixation

Sponsors

Pongsatorn Pholkerd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. age between 18 and 60 years and 2. unstable distal clavicle fracture classified as Neer type II or V.

Exclusion criteria

Exclusion criteria: 1. previous clavicular fracture 2. concomitant ipsilateral upper extremity fracture 3. previous shoulder surgery 4. open fracture 5. associated neurovascular injury.

Design outcomes

Primary

MeasureTime frame
Clinical outcome at 3-month follow up Constant-Murley Score

Secondary

MeasureTime frame
Pain intensity at 3-month follow up visual analog scale,Radiographic outcome at 3-month follow up Coracoclavicular distance (CC-distance)),Radiographic outcome at 3-month follow up Radiographic union rate,Post-operative Complication at 3-month follow up Post-operative Complication,Implant cost At date of operation Implant cost

Countries

Thailand

Contacts

Public ContactPongsatorn Pholkerd

Roi-Et hospital

pongsatornpholkerd@gmail.com0804516598

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026