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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
| Region Östergötland | OTHER |
| Region Västerbotten | OTHER_GOV |
| Region Örebro County |
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Flexor tendon injuries in the thumb occur across all ages and genders. Each year, approximately 400 patients undergo surgery for a flexor tendon injury in Sweden. These injuries are exclusively treated at one of the seven specialized hand surgery clinics, as the surgery is technically demanding, and postoperative rehabilitation is critical, specialized, and requires expertise from hand therapists. To prevent tendon adhesions and stiffness in the thumb or fingers, controlled active motion therapy is usually initiated within a few days after surgery. Studies on finger flexor tendon injuries have shown that early active movement therapy leads to better mobility compared to immobilization. Consequently, early active training is now the standard treatment following flexor tendon repair. However, during postoperative rehabilitation, the repaired flexor tendon may rupture, often necessitating revision surgery.
The rupture rate after flexor tendon repair in the thumb is approximately three times higher than in other fingers (10% vs. 3%). While most studies on flexor tendon injuries focus on finger tendons, research on the outcomes of thumb flexor tendon injuries is limited. The biomechanics and anatomy of the thumb's flexor tendon differ significantly from those of finger tendons.
The objective of this study is to determine whether the rupture rate following thumb flexor tendon surgery can be reduced by immobilizing the thumb in a cast for four weeks postoperatively, compared to standard early active motion therapy, without negatively affecting joint mobility and thumb strength. Additionally, the study will evaluate patient-reported outcomes one year post-surgery for both rehabilitation regimens (immobilization vs. mobilization).
This study is a registry-randomized clinical trial (RRCT) involving five hand surgery clinics in Sweden. Data following randomization between the two rehabilitation protocols will be collected through follow-up in the Swedish National Hand Surgery Quality Registry (HAKIR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early active motion | Active Comparator | Early active motion 2-5 days postoperatively. |
|
| Immobilisation in plaster cast 4 weeks | Active Comparator | Immobilisation in plaster cast 4 weeks postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early active motion training after operated FPL injury | Other | Early active motion training after operated FPL injury |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tendon rupture rate | Clinically diagnosed rupture of an operated flexor pollicis longus injury | Within one year after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Active range of motion in the joints of the operated thumb MCP joint | Active range of motion of the MCP joint of the operated thumb measured with a goniometer | 3 and 12 months postoperatively |
| Active range of motion of the IP-joint in the opererated thumb |
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Inclusion Criteria:
Complete laceration of the thumb flexor tendon (Flexor Pollicis Longus; FPL) within zone 1 and 2.
Age over 15 years. Minors (<18 years) are considered to have sufficient maturity to understand the implications of the research.
Swedish-speaking / able to understand spoken and written Swedish. Surgery performed within 14 days from the time of injury.
Exclusion Criteria:
Tendon injury with a defect requiring tendon grafting. Another complete tendon injury in the same hand. Extensive associated injuries, such as fracture, vascular injury with circulatory impairment, large skin defect, or preoperative signs of infection. Patient deemed unsuitable for early active motion therapy due to factors such as lack of cooperation, cognitive impairment, or substance abuse issues.
Patient declines follow-up in the HAKIR quality registry. Wound infection making early active motion therapy inappropriate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Wilcke, MD, Associate professor | Contact | +46812362022 | maria.wilcke@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus | Recruiting | Linköping | Sweden |
Deidentified data might be shared upon request for metaanalyses.
After the results are analyzed and publish and 10 years ahead
Researchers with an ethical permitt, as descibed above, by request to maria.wilcke@ki.se
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| OTHER |
| Uppsala County Council, Sweden | OTHER_GOV |
Registry-randomized controlled trial (RRCT)
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| Immobilisation in plaster cast 4 weeks after operated FPL injury | Other | Immobilisation in plaster cast 4 weeks after operated FPL injury |
|
Measured with a goniometer |
| 3 and 12 months postoperatively |
| Grip strength | Measured using a Jamar dynamometer and compared to the uninjured side.gauge. | 3 and 12 months postoperatively |
| Key pinch strength | Key pinch between the thumb and index finger assessed with a pinch gauge. | 3 and 12 months postoperatively |
| HQ-8 questionnaire | A Patient-rated outcome measurse (PROM).The HAKIR questionnaire (HQ-8) consists of seven questions regarding symptoms in the operated hand, such as aching, pain, numbness, weakness, and cold sensitivity, as well as one question on perceived hand function. All questions are answered on a 0-100 scale (0, 10, 20, etc.). An additional question in the questionnaire addresses satisfaction with the surgical outcome, rated from completely dissatisfied to completely satisfied. | 3 and 12 months postoperatively |
| Quick DASH | A patient-rated outcome measure (PROM). The short version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) contains 11 questions covering activity limitations, symptoms, and participation. The responses are summed into a total score ranging from 0 to 100, where 100 represents maximum perceived disability of the hand and arm. | 3 and 12 months postoperatively |
| Overall satisfaction with rehabilitation | Five-point Likert scale of overall satisfaction with rehabilitation: the five response options are: (1) Yes, to a very large extent, (2) Yes, to a large extent, (3) To a certain extent, (4) To a small extent, and (5) Not at all. | 3 and 12 months |
| Handkirurgiska kliniken Örebros Universitetssjukhus | Recruiting | Örebro | Sweden |
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| Handkirurgiska kliniken Södersjukhuset | Recruiting | Stockholm | Sweden |
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| Handkirurgiska kliniken Norrlands Universitetssjukhus | Recruiting | Umeå | Sweden |
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| Handkirugiska kliniken Uppsala Akademiska Sjukhus | Recruiting | Uppsala | Sweden |
|
| ID | Term |
|---|---|
| D007103 | Immobilization |
| D002370 | Casts, Surgical |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D053831 | Surgical Fixation Devices |
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