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NCT01998594 · ClinicalTrials.gov registry record · Phase 4
Use of FlexHD as Post Trapeziectomy Spacer
A Phase 4 study of Osteoarthrosis of the Carpometacarpal Joint of the Thumb, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01998594: Completed Phase 4 study of Osteoarthrosis of the Carpometacarpal Joint of the Thumb, sponsored by Cedars-Sinai Medical Center.
NCT01998594 is a Phase 4 study of Osteoarthrosis of the Carpometacarpal Joint of the Thumb that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01998594, a Phase 4 study of Osteoarthrosis of the Carpometacarpal Joint of the Thumb, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space created by removal of the trapezium improves the subject's outcome and subsequent functionality of the basilar joint arthroplasty procedure.
Primary Outcome
The objective of this study is to determine whether utilizing HADM will result in increased functionality measured by: * DASH score * Pinch and grip strength * Pain scale * Quality of life scores and * Trapezial space on radiographs at designated intervals during the post-operative period
Conditions Studied
Interventions
- PROCEDURE Arthroplasty
Study Locations (1)
California
- Cedars-Sinai Department of Hand Surgery - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
What the finished NCT01998594 record still lists
NCT01998594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Osteoarthrosis of the Carpometacarpal Joint of the Thumb appearing as the primary indexed condition, and to 1 intervention - of which Arthroplasty is the first listed.
NCT01998594 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01998594 about?
NCT01998594 is a clinical study titled "Use of FlexHD as Post Trapeziectomy Spacer". The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space created by removal of the trapezium improves the subject's outcome and subsequent functionality of the basilar joint arthroplasty procedure.
What is the current status of trial NCT01998594?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2013-08. Estimated completion is 2017-12.
What conditions does trial NCT01998594 study?
This clinical trial studies the following conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb.
What interventions are being tested in trial NCT01998594?
The interventions under investigation include: Arthroplasty (PROCEDURE).
Who is sponsoring clinical trial NCT01998594?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01998594 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01998594's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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