An observational study in Distal Radius Fracture, sponsored by Vastra Gotaland Region. Recruiting at 1 site in Sweden. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Vastra Gotaland Region · Observational
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Among 19 studies in Wrist Fractures with a site in Sweden — 4 open to participants now, 6 under way, none of them phase 3. Wrist Fractures · Sweden.
Among the 19 studies in Wrist Fractures with a site in Sweden, this one is one of 4 that started in 2022, is one of 5 observational ones, and was the 13th registered.
330 studies on the registry are indexed under Wrist Fractures; 72 are open to participants now.
Browse Wrist Fractures studies →4 of the 19 studies in Wrist Fractures with a site in Sweden are open now. Recruiting first, the newest first:
Tampere University Hospital · Sites in Sweden, Denmark, Estonia and 1 more country
Ages 65+
Sahlgrenska University Hospital · Sites in Sweden
Ages 18+
Region Skane · Sites in Sweden
Ages 18+
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 43 Wrist Fractures studies recruiting now, 20 (47%) set no upper age limit and 15 (35%) stop at 75 or younger; 7 take children under 18; 6 take healthy volunteers.
This study: 16 Years and older · all sexes.
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19 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 4 started in 2022.
This study's planned enrollment of 60 is below the median of 100 across 53 observational studies indexed under Wrist Fractures.
Median enrollment 105 across the 14 interventional studies, 45 across the 4 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
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1 of 19 have an industry lead sponsor. The 10 most frequent:
Vastra Gotaland Region is the lead sponsor of 276 studies on the registry; 110 are open to participants now.
Vastra Gotaland Region has 1 study filed under Wrist Fractures — fewer than ten, so there is no comparison to draw.
2 of the studies in Wrist Fractures with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07553000Region SkaneSplinted Wrist Study | 2026-12-30 |
| NCT05818241Sahlgrenska University HospitalSatisfaction and Recovery After Distal Radius Fracture | 2027-01-31 |
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Among the 19 studies in Wrist Fractures with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Rupture of the extensor pollicis longus, (EPL) is a common complication after distal radius fractures. A rupture prevents the thumb extension, which in turn has a negative impact on hand function. An EPL-rupture can either be surgically treated by primary suture, which means that the ends of the tendon are sutured. This is however not recommended if the tendon is weakened. In such cases the rupture can be treated by a transfer of, most often, extensor indicis proprius (EIP) to the thumb.
Distal radius fractures are common and a rupture of the EPL-tendon is a known complication thar interferes with hand function and therefore more studies on this patient group are warranted.
The aim of this prospective study is to compare regaining of thumb function after surgery, with the non-injured side, after primary suture and EIP-transfer after EPL-rupture as a complication following distal radius fracture.
Rupture of the long extensor tendon of the thumb (extensor pollicis longus, EPL) is a common complication after distal radius fracture. The incidence has been shown to be about 1% after surgical treatment of the fracture and up to 5% after non-surgical treatment.
The reason why the tendon ruptures after minimally displaced fractures may be reduced blood flow to the tendon. After surgical treatment of a fracture, the cause of rupture may be irritation of the tendon caused by the osteosynthesis material. A rupture means that the thumb cannot be extended, which affects the function of the hand negatively.
EPL rupture can either be operated with primary suture, which means that the ends of the tendon are found and sutured, however this is not recommended if the tendon is weakened, for example due to poor vascularisation. In such a case, the EPL rupture can be repaired by moving a tendon, (usually the extensor indicis proprius, EIP), to the thumb .
Previous studies focusing on function after EPL rupture have been small and have not differentiated EPL ruptures with different underlying causes and the regimen of post-operative care has not been uniform.
Since distal radius fracture is a very common injury and rupture of the EPL tendon is a known complication that affects hand function, it is important that more studies are done on this patient group. Function should be evaluated both with objective and patient-related outcome measures. Knowledge of function after surgery is important for patients, surgeons and rehabilitation staff.
Purpose
The purpose of the present prospective study is to compare recovery of thumb function relative to the non-injured side after primary suture and EIP transfer respectively in rupture of the EPL after distal radius fracture.
Questions
How do patients rate their function after primary suture or EIP transfer?
How much recovery of thumb function occurs relative to the non-injured hand?
Do the groups differ in these respects?
Intervention
After primary suture/tendon transfer and cast immobilization (4 weeks after primary suture and 2 weeks after tendon transfer, respectively), patients will begin exercise according to a specific exercise program for thumb mobility. Between training sessions, an individually adapted, static splint is used with the thumb in extension (2 weeks after primary suture and 4 weeks after tendon transfer, respectively).
Six weeks postoperatively, free mobilization is allowed in light activities of daily living with progressively increased load and training according to the program continues.After twelve weeks, the patient has no restrictions regarding load.
Data collection will take place at 3 and 6 months postoperatively,
The grouping will be based on the treatment method chosen by the surgeon as this is related to the nature of the injury.
Power calculation
A power calculation was made based on the assumption that the group has a mean QuickDASH score of 25 points (SD 8) preoperatively and that the difference between the groups would be 6.8 points, which corresponds to "minimal clinically important difference". To reach a power of 0.80 with alpha 0.05, 22 patients per group are needed. To compensate for a presumed dropout, 30 patients per group are planned to be included.
The patients will be selected via the planning system for operations. The inclusion is expected to last for up to two years.
Data processing
Grip and pinch strength and mobility will be calculated as a percentage of the non-injured side and an average of the percentage will be calculated. Any statistical difference between operated and non-operated side and between the groups will be calculated with t-test.
Expected result / Clinical significance
The expected result is that the patients regain a large part of their function, which is of great importance for the individual patient, no difference between the groups is expected to emerge.
The study is expected to confirm that the treatment regimens used work well, which is important as Sahlgrenska University Hospital strives to use evidence-based treatment methods.
Patients with distal radius fractures who suffer from rupture of the EPL-tendon
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
primary suture of EPL
Procedure: primary suture
transfer of the EIP to EPL
Procedure: EIP-transfer
Primary suture of the EPL-tendon
transfer of the EIP-tendon to the EPL-tendon
range of motion
extension, flexion, abduction, retroposition of thumb
Time frame: 3 months postoperatively
range of motion
extension, flexion, abduction, retroposition of thumb
Time frame: 6 months postoperatively
strength
pinch, lateral pinch, grip strength
Time frame: 3 months postoperatively
strength
pinch, lateral pinch, grip strength
Time frame: 6 months postoperatively
Quick-DASH (Disabilities of the Arm, Shoulder and Hand)
Patient rating of function. Minimum score 0 points, maximum score 100 points. Higher scores indicate a worse outcome.
Time frame: 3 months postoperatively
Quick-DASH (Disabilities of the Arm, Shoulder and Hand)
Patient rating of function. Minimum score 0 points, maximum score 100 points. Higher scores indicate a worse outcome.
Time frame: 6 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Apr 2026, 51 months after the start.
Of 20 observational studies under Wrist Fractures, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 63. This study's planned 51 months is above that.
How these figures are worked out, and which studies are left out of them.
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