Here is the design of a clinical trial:

Official Title: Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

Included conditions:
- Spinal Cord Injuries

Study Armgroups:
- {'label': 'Duroplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'Duroplasty (includes Surgery with Laminectomy)', 'interventionNames': ['Procedure: Duroplasty', 'Procedure: Spinal surgery']}
- {'label': 'No duroplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'No duroplasty (but includes surgery with Laminectomy)', 'interventionNames': ['Procedure: Spinal surgery']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Duroplasty', 'description': 'Expansion Duroplasty', 'armGroupLabels': ['Duroplasty']}
- {'type': 'PROCEDURE', 'name': 'Spinal surgery', 'description': 'Spinal surgery including laminectomy', 'armGroupLabels': ['Duroplasty', 'No duroplasty']}

Primary Outcomes:
- {'measure': 'Change in AIS motor score', 'description': 'Change in American Spinal Injury Association Impairment Scale total limb motor score at 6 months', 'timeFrame': '6 months versus baseline'}

Please estimate the sample size based on the assumption: 
15% patient loss to follow-up by 6 months, statistical power of 85%, 2-sided significance level of 5%. Statistical power may be revised to 90% if recruitment figure of 260 is achievable.
Sample size {14}
        Assuming a 6-month improvement in change in AIS motor score (ÎAMS) from a mean (SD) of 17 (25) in the control arm to 28 (25) in the intervention arm, allowing for 15% patient loss to follow-up by 6 months (including patient death which is estimated to be around 2â3% by 6 months), a total sample size of 222 patients is required with statistical power of 85% and 2-sided significance level of 5%. The assumed difference in ÎAMS and SD are based on our exploratory study [7] and are supported by data from the European Multicenter Study about Spinal Cord Injury (EMSCI) database and other published series [16, 17] in which ÎAMS is between 15 and 18 with SD ranging from 15 to 25. While recruitment is in progress, the statistical power will be revised from 85 to 90% if it becomes clear that the new recruitment figure (N = 260) is achievable. The final decision to increase recruitment will be made by the TSC.
        
          Mechanistic study
          Since the proposed mechanistic studies are intended to be hypothesis-generating, no formal sample size calculation has been performed.