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| ID | Type | Description | Link |
|---|---|---|---|
| FoUI-1022484 | Other Grant/Funding Number | ALF Region Stockholm |
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| Name | Class |
|---|---|
| Uppsala University | OTHER |
| Umeå University | OTHER |
| University of Oslo | OTHER |
| Tampere University |
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Background Metacarpal shaft fractures account for 30-50% of hand fractures (Karl et al., 2015; Kollitz et al., 2014; van Onselen et al., 2003), with diaphyseal spiral and oblique fractures of the second to fifth ray posing unique challenges due to the risks of shortening and rotational deformities. Current standard care of displaced fractures involves operative fixation.
However, retrospective studies have indicated that nonoperative treatment, involving early mobilization or buddy taping, can achieve outcomes comparable to operative treatment (Daher et al., 2023). There is only one published, with a small sample size, randomized controlled trial (RCT) investigating this issue (Peyronson et al., 2023). This highlights the need for a robust multicenter RCT to address these gaps in evidence.
Aim The aim of this study is to compare the one-year outcomes of non-operative treatment involving immediate unrestricted mobilization versus operative treatment of displaced oblique or spiral diaphyseal metacarpal fractures in adults.
Materials and Methods This is a multicenter, pragmatic, prospective, noninferiority RCT involving 552 adult patients with displaced oblique and/or spiral diaphyseal metacarpal fractures of the second to fifth ray. Participants will be randomized 1:1 to receive either nonoperative treatment with unrestricted mobilization and rehabilitation) or operative treatment (with screw or plate fixation) followed by rehabilitation.
The primary outcome is grip-strength in the injured hand presented in kilograms at one year.
Secondary outcomes include questionnaires, complications, range of motion, patient reported outcome measures, health related quality of life, patient satisfaction, and radiographic healing.
A power calculation proposes a study size of 552 participants to detect a noninferiority margin of 10% in grip strength.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-operative with early mobilization | Experimental | Participants randomized to the nonoperative group will receive immediate unrestricted mobilization, with optional buddy taping or removable splinting for comfort. Closed reduction will not be attempted. Rehabilitation protocol with early mobilization will be standardized across study centers with printed standardized information to patients and rehabilitation staff. |
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| Operative | Active Comparator | Participants randomized to the operative group will undergo open reduction and internal fixation (ORIF) of the MSF. Peri-operative antibiotic prophylaxis will be administered according to local guidelines. The surgical approach and fixation method (e.g. compression screws and/or plate, not K-wires) will be at the discretion of the treating surgeon, following standard surgical principles. Postoperative immobilisation will adhere to surgeons' preference but not exceed two weeks fixation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-operative treatment with early mobilization | Procedure | Participants randomized to the nonoperative group will receive immediate unrestricted mobilization, with optional buddy taping or removable splinting for comfort. Closed reduction will not be attempted. Rehabilitation protocol with early mobilization will be standardized across study centers with printed standardized information to patients and rehabilitation staff. |
| Measure | Description | Time Frame |
|---|---|---|
| Grip strength | The primary outcome is grip-strength measured in the injured hand using a JAMAR dynamometer at 12 months and presented in kilograms. Measurement method will follow the technical description presented in the HAKIR manual (HAKIR, 2023). | From enrollment to the end of follow-up at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | infection, malunion, nerve injury, reoperation | From enrollment to the end of follow-up at 12 months |
| Pain in injured hand NRS | NRS (Numerical Rating Scale) at rest and when it is at its worst |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cecilia Mellstrand Navarro, Associate professor | Contact | +46709280114 | cecilia.mellstrand.navarro@ki.se | |
| Elsa Pihl, PhD | Contact | +46739705669 | elsa.pihl@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet, Danderyd's hospital | Recruiting | Stockholm | Stockholm County | 18288 | Sweden |
Data on group level will be made available upon reasonable request.
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| ID | Term |
|---|---|
| D004434 | Early Ambulation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| OTHER |
| Københavns Universitet | OTHER |
| Göteborg University | OTHER |
| Linkoeping University | OTHER_GOV |
| Region Stockholm | OTHER_GOV |
| Östersunds Hospital | OTHER |
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| Operative treatment | Procedure | Participants randomized to the operative group will undergo open reduction and internal fixation (ORIF) of the MSF. Peri-operative antibiotic prophylaxis will be administered according to local guidelines. The surgical approach and fixation method (e.g. compression screws and/or plate, not K-wires) will be at the discretion of the treating surgeon, following standard surgical principles. Postoperative immobilisation will adhere to surgeons' preference but not exceed two weeks fixation. |
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| From enrollment to the end of follow-up at 12 months |
| Rotational deformity | 0 - no deformity, 1 - minimal deformity, 2 - clearly visible deformity but acceptable functional limitation, 3 - great deformity and functional limitation | 12 months |
| PROM - patient rated outcome measure | Quick-DASH-9 score (Gabel et al., 2009) | 6, 12 weeks, 12 months |
| Range of motion | total active motion and extension lag | 6, 12 weeks, 12 months |
| Pinch grip strength | 12 weeks, 12 months |
| Radiographic shortening | according to Sletten (Sletten et al., 2013) | 12 months |
| Radiographic healing | defined as bridging callus formation over the fracture line on a plain x-ray anterio-posterior and/or lateral projection. (Hayes et al., 2023) | 12 weeks, 12 months |
| Sick leave duration | in days | 12 months |
| Patient satisfaction | Patient Acceptable Symptom State, PASS (Daryoush et al., 2025) | From enrollment to the end of follow-up at 12 months |
| Quality of life measured by PROM | EQ-5D EuroQol Group, 1990; Taft et al., 2004) | From enrollment to the end of follow-up at 12 months |
| Quality of life measured by SF-12 | SF-12 (EuroQol Group, 1990; Taft et al., 2004) | From enrollment to the end of follow-up at 12 months |
| D013812 |
| Therapeutics |