UMIN ID: UMIN000002005
Registered date:01/06/2009
Effects of low-intensity pulsed ultrasound (LIPUS) treatment in post-operative scaphoid delayed unions or nonunions: multi-institutional prospective randomized controlled trial
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | scaphoid delayed unions and nonunions |
| Date of first enrollment | 2009/06/01 |
| Target sample size | 86 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | The scaphoid delayed unions or nonunions were treated with internal screw fixation with bone grafting The scaphoid delayed unions or nonunions were treated with internal screw fixation with bone grafting, and LIPUS treatment was started within ten days after surgery and consisted on one twenty-minute period each day for 16 weeks after surgery. |
Outcome(s)
| Primary Outcome | The end-point of the study is a healed period of the scaphoid delayed unions or nonunions, as judged on CT examination |
|---|---|
| Secondary Outcome | 1) Functional outcomes are assessed with the Disability of the Arm, Shoulder, and Hand Japanese version (DASH-JSSH) 2) The study is a healed period of the scaphoid delayed unions or nonunions, as judged on radiographic examination 3) Functional outcomes are assessed with the Visual Analog Scale (VAS) for pain 4) Functional outcomes are assessed with the grip strength improvement at pre-operation, and 16 weeks after operation period. 5) Functional outcomes are assessed with the Range of motion of the wrist improvement at pre-operation, and 16 weeks after operation period. |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Scaphoid partially united fractures 2) The scaphoid delayed unions or nonunions treating with vascularized bone grafting 3) The patient presented arthritis of the wrist 4) The proximal pole nonunions with avascular necrosis, which was proved with MRI 5) The patient receiving LIPUS treatment before 6) The patient receiving electrical stimulation 7) The patient who is unable to apply LIPUS treatment 8) The patient had recent severe systemic past history such as heart, liver or kidney disease 9) The patient had treated cancer therapy within recent five years 10) The patient is pregnant or possible pregnant 11) The patient entering for other medical trials 12) The patient who is unable to comply with this study protocol 13) The patient who is unable to comply with the consent form of this study 14) The patient who was recognized unsuitable for this study by primary physician |
Related Information
| Primary Sponsor | Japanese Society for Surgery of the Hand, Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Teijin Pharma Limited |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Koichi Hashimoto |
| Address | 1-1-1 Tennodai, Tsukuba, Ibaraki Japan |
| Telephone | 029-853-3326 |
| koichi.hashimoto@md.tsukuba.ac.jp | |
| Affiliation | University of Tsukuba Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL) |
| scientific contact | |
| Name | Hiromichi Mitsuyasu1), Naoyuki Ochiai2) |
| Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka1), 1-1-1 Tennodai, Tsukuba, Ibaraki2) Japan |
| Telephone | 092-642-5488 |
| Affiliation | Kyushu University, Graduate School of Medical Sciences1), University of Tsukuba2) Orthopaedic Surgery1), Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL)2) |