Comparison of titanium Herbert screw osteosynthesis of SCAphoid fractures with osteosynthesis by the bioabsorbable compression screw MAGNEZIX® CS: The randomized controlled multicentre trial SCAMAG

Phase 4

Recruiting

Conditions: S62.0
Fracture of navicular [scaphoid] bone of hand

Registration Number: DRKS00013368

Lead Sponsor: Syntellix AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 190

Inclusion Criteria

1. Indication for screw fixation of scaphoid fracture which is not older than 12 weeks; classification by Herbert, modified by Krimmer of types A2, B1, B2, B3 (Krimmer et al., 2000a),
2. normal wrist function prior to fracture,
3. age =16 years,
4. written informed consent.

Exclusion Criteria

1. Previous surgery on the wrist, associated injuries, state after or suspicion of complex regional pain syndrome (CRPS),
2. simultaneous fractures of the forearm of both sides and those who will influence the postoperative care,
3. ligamentary concomitant injuries of the wrist on both sides and those who will influence the post-operative care,
4. radiological findings of losing calcium carbonate in bones,
5. pregnancy, suspected pregnancy or breastfeeding period,
6. allergies to components of osteosynthesis material,
7. participation in other clinical trials up to 30 days before inclusion in this trial,
8. neurological deficits,
9. for patients recruited to the Hanover center and undergoing MRI: claustrophobia and metallic implants which are contraindicative for an MRI.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First primary endpoint: patient-related wrist evaluation (PRWE) total score after 6 months.<br><br>Second primary endpoint: dichotomous and scored =1 if:<br>- an adverse device effect occurred during surgery and/or<br>- an adverse device effect occurred during the wound healing period and/or<br>- a servere adverse device effect occurred during the 1-year follow-up period and/or<br>- a reoperation was performed during the 1-year follow-up period and/or<br>- there was no or incomplete bone union until 6 months after randomization.<br><br>Third primary endpoint: difference between maximum length of an artifact in MRI between 1-year follow-up and baseline. Measured only in those patients participating in the MRT part of the trial.

Secondary Outcome Measures

Name	Time	Method
- PRWE total score at 3 and 12 months.<br>- PRWE domains pain and function at months 3, 6 and 12.<br>- Disabilities of the Arms, Shoulder and Hands questionnaire (DASH) total score at 3, 6 and 12 months.<br>- DASH optional module scores sport/music at 3, 6 and 12 months.<br>- DASH optional module scores work at 3, 6 and 12 months.<br>- Krimmer Wrist Score (KWS) total score at months 3, 6 and 12.<br>- Domains of the KWS at months 3, 6 and 12.<br>- Wrist function using range of motion as measured with a goniometer at months 3, 6 and 12.<br>- Grip strength as measured with a dynamometer at months 3, 6 and 12.<br>- Bone union as measured by imaging (X-ray, CT -- according to guideline) at month 6.<br>- Quality of life (EQ-5D-5L) at months 3, 6 and 12.<br>- Return to work and recreational activities (time to event).<br>- Edema in MRI at months 3, 6, 9 and 12.