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Prospective cohort study on the impact of arthroscopically diagnosed concomitant injuries of the scapholunate ligament, lunotriquetral ligament, and triangular fibrocartilage complex on functional outcomes in patients with distal intra-articular radius fractures

Prospective cohort study on the impact of arthroscopically diagnosed concomitant injuries of the scapholunate ligament, lunotriquetral ligament, and triangular fibrocartilage complex on functional outcomes in patients with distal intra-articular radius fractures - SCOPE-DRF

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00040865
Enrollment
100
Registered
2026-07-03
Start date
2026-06-01
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

S52.59

Interventions

Group 1: Patients with distal intra-articular radius fractures WITHOUT concomitant ligament injuries will undergo follow-up assessments at regular intervals for up to 5 years after fracture treatment

Sponsors

Universitätsklinikum Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Age = 18 years -Acute, closed, intra-articular distal radius fracture confirmed by imaging -Indication for surgical treatment with open reduction and internal fixation (ORIF) -Capacity to provide informed consent and written consent to participate in the study and attend the follow-up examinations

Exclusion criteria

Exclusion criteria: -Open fractures -Polytrauma with an Abbreviated Injury Scale (AIS) score = 3 if adequate follow-up cannot be ensured -Pre-existing symptoms and/or previous surgery involving the affected wrist, such as a known unstable scapholunate ligament injury, rheumatoid arthritis, or severe degenerative joint disease -Neurological disorders resulting in permanent impairment of hand function -Refusal to undergo arthroscopic examination -Pregnancy

Design outcomes

Primary

MeasureTime frame
Difference in the total Patient-Rated Wrist Evaluation (PRWE) score between patients with and without concomitant wrist/carpal injuries at 12 months, 24 months, and 5 years after the fracture.

Secondary

MeasureTime frame
Secondary endpoints: - PRWE score at 6 weeks, 3 months, and 6 months -DASH score at 3, 6, 12, and 24 months and at 5 years - Visual analogue scale (VAS) for pain at rest and during activity -Range of motion, including active flexion and extension, radial and ulnar deviation, and pronation and supination, reported both as absolute values and as a percentage of the contralateral side - Grip strength measured using a dynamometer in kilograms and compared with the contralateral side - Radiographic parameters: o Standard radiographs in anteroposterior, lateral, and oblique views obtained immediately postoperatively and at 6 weeks, 3, 6, 12, and 24 months, with optional imaging at 5 years oComputed tomography (CT) for the assessment of intra-articular reduction and complex fracture fragments oAssessment of post-traumatic osteoarthritis using a predefined scoring system, such as the modified Knirk and Jupiter classification or a study-specific radiographic osteoarthritis scale, at 12 and 24 months and at subsequent follow-up visits - Complications and reoperations, including infection, implant failure, and subsequent wrist procedures - Nerve-related adverse events, such as carpal tunnel syndrome

Countries

Germany

Contacts

Public ContactNaemi Reyersbach

Universitätsklinikum Regensburg

naemi.reyersbach@ukr.de+491781571307

Outcome results

None listed

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