Comparing immediate mobilization to 2 weeks of casting after wrist surgery
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate - a Study Protocol for a Prospective, Randomized, Controlled Trial
This study is testing if moving your wrist right after surgery helps people with wrist fractures recover faster and feel better compared to wearing a cast for two weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 2 sites (Jyväskylä and 1 other locations) |
| Trial ID | NCT05150925 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, randomized, controlled trial aimed at comparing the early postoperative outcomes of patients who undergo immediate mobilization versus those who receive 2 weeks of casting after surgery for a distal radius fracture treated with a volar locking plate. The primary outcomes measured will be the total length of sick leave and the Patient-Rated Wrist Evaluation (PRWE) score at 2 months post-operation. By analyzing these outcomes, the study seeks to determine the effectiveness of early mobilization in improving recovery times and functional outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with intra- or extra-articular distal radius fractures requiring surgical treatment.
Not a fit: Patients with open fractures of greater severity, those with previous wrist fractures affecting function, or those with polytrauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and better functional outcomes for patients with distal radius fractures.
How similar studies have performed: Other studies have shown promising results with early mobilization approaches in similar orthopedic conditions, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intra- or extra articular DRF (Colles, Smith, Volar barton) * operative treatment justified Exclusion Criteria: * Refusal to participate in the study * Open fracture with a severity greater than Gustilo grade 1 * Patient aged less than 18 or over 65 * Patient does not understand written or spoken guidance in local languages * Pathological fracture * Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function * Ipsilateral fracture in upper extremity * Associated fractures of the ulna (except fractures of the PSU) * Polytrauma
Where this trial is running
Jyväskylä and 1 other locations
- Teemu Karjalainen — Jyväskylä, Finland (Recruiting)
- Laura Kärnä — Tampere, Finland (Recruiting)
Study contacts
- Study coordinator: Laura Kärnä, MD
- Email: laura.karna@pshp.fi
- Phone: +3583311611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.