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The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.
Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Immediate fitting with dynamic splinting following diagnosis of hallux limitus. |
|
| 2 | No Intervention | Control arm; patients only treated with standard of care following diagnosis of hallux limitus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metatarsophalangeal Extension Dynasplint System | Device | Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn for 30 minutes, three times per day, (while seated or resting in bed) totaling 1.5 hours per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Active Range of Motion of Hallux (great toe) Extension | Two Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in passive Range of Motion, Extension | same |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley R Kalish, DPM, FACFAS | Atlanta Foot and Leg Clinic | Principal Investigator |
| Buck Willis, PhD | Dynasplint Systems, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Foot and Leg Clinic | Jonesboro | Georgia | 30236 | United States | ||
| Ankle and Foot Centers, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17144945 | Background | Goucher NR, Coughlin MJ. Hallux metatarsophalangeal joint arthrodesis using dome-shaped reamers and dorsal plate fixation: a prospective study. Foot Ankle Int. 2006 Nov;27(11):869-76. doi: 10.1177/107110070602701101. | |
| 10416546 | Background | Hockenbury RT. Forefoot problems in athletes. Med Sci Sports Exerc. 1999 Jul;31(7 Suppl):S448-58. doi: 10.1097/00005768-199907001-00006. |
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| ID | Term |
|---|---|
| D020857 | Hallux Limitus |
| ID | Term |
|---|---|
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care | Other | The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position. |
|
| Marietta |
| Georgia |
| 30066 |
| United States |
| Background | Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus (Pilot Study). BioMechanics, 2007 Sept;14(9), pg49-53 |
| 17296132 | Background | Brodsky JW, Baum BS, Pollo FE, Mehta H. Prospective gait analysis in patients with first metatarsophalangeal joint arthrodesis for hallux rigidus. Foot Ankle Int. 2007 Feb;28(2):162-5. doi: 10.3113/FAI.2007.0162. |
| 15778469 | Background | Talarico LM, Vito GR, Goldstein L, Perler AD. Management of hallux limitus with distraction of the first metatarsophalangeal joint. J Am Podiatr Med Assoc. 2005 Mar-Apr;95(2):121-9. doi: 10.7547/0950121. |
| 12015407 | Background | Payne C, Chuter V, Miller K. Sensitivity and specificity of the functional hallux limitus test to predict foot function. J Am Podiatr Med Assoc. 2002 May;92(5):269-71. doi: 10.7547/87507315-92-5-269. |
| 16467621 | Background | Kennedy JG, Chow FY, Dines J, Gardner M, Bohne WH. Outcomes after interposition arthroplasty for treatment of hallux rigidus. Clin Orthop Relat Res. 2006 Apr;445:210-5. doi: 10.1097/01.blo.0000201166.82690.23. |
| 12095117 | Background | DeFrino PF, Brodsky JW, Pollo FE, Crenshaw SJ, Beischer AD. First metatarsophalangeal arthrodesis: a clinical, pedobarographic and gait analysis study. Foot Ankle Int. 2002 Jun;23(6):496-502. doi: 10.1177/107110070202300605. |
| 17972321 | Background | Canseco K, Long J, Marks R, Khazzam M, Harris G. Quantitative characterization of gait kinematics in patients with hallux rigidus using the Milwaukee foot model. J Orthop Res. 2008 Apr;26(4):419-27. doi: 10.1002/jor.20506. |
| Background | Becher C, Kilger R, Thermann H. Results of cheilectomy and additional microfracture techniques for the treatment of hallux rigidus. Foot Ankle Surg. 2005;(10): 155-160 |
| 11475452 | Background | Lau JT, Daniels TR. Outcomes following cheilectomy and interpositional arthroplasty in hallux rigidus. Foot Ankle Int. 2001 Jun;22(6):462-70. doi: 10.1177/107110070102200602. |
| Background | Willis B. Dancers restore knee flexion through dynamic splinting. BioMechanics. 2008;Jan;15(1), pg49-54 |
| D018409 |
| Foot Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |