## Protocol Section
### Identification Module
**NCT ID:** NCT01589679

**Acronym:** Bunionectomy

**Brief Title:** Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

**Official Title:** Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial

#### Organization Study ID Info
**ID:** DYN1-12-047
#### Organization
**Class:** INDUSTRY
**Full Name:** Dynasplint Systems, Inc.
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-08-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-08-08

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2016-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2012-04

**Status Verified Date:** 2013-08

#### Study First Post Date
**Date:** 2012-05-02
**Type:** ESTIMATED
**Study First Submit Date:** 2012-04-30
**Study First Submit QC Date:** 2012-04-30
**Why Stopped:** Unrelated to Trial
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Dynasplint Systems, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.

### Conditions Module

**Conditions:**

- Hallux Limitus

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** ALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Control subjects will be treated with the Standard of Care during the first 12 weeks, but after the 12 weeks patients will be fit with MTP, which delivers a low-load, prolonged-duration stretch after completion of this study.

**Intervention Names:**

- Other: standard of care

**Label:** control/ standard of care

**Type:** OTHER

#### Arm Group 2

**Description:** ALL SUBJECTS WILL RECEIVE SHOE INSERTS AND HOME STRETCHING REGIME. Experimental subjects will be immediated treated with the Metatarsal Dynasplint, which delivers a low-load, prolonged-duration stretch for 60 minutes, three times per day.

**Intervention Names:**

- Device: Metarsal Dynasplint

**Label:** Dynasplint

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- control/ standard of care

**Description:** 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 work for 60 minutes three times per day.

**Name:** standard of care

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Dynasplint

**Description:** 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 work for 60 minutes three times per day.

**Name:** Metarsal Dynasplint

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** ANOVA will be performed to measure different in category, pain, duration to full restoration of active range of motion(AROM).

**Measure:** A Repeated Measures Analysis of Variance (ANOVA)

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis 1st MTJ Contracture following Bunionectomy

Exclusion Criteria:

* Current treatment with Botulinium Toxin-A (Botox), lower extremity
* Current treatment Fluoroquinolones (antibiotic medication)
* Current use of muscle relaxant medications
* Fibromyalgia
* Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
* Treatment with electrical stimulation assisting ambulation (i.e Bioness, WalkAide, Parastep, etc.)

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Tufts Medical Center

**State:** Massachusetts

**Zip:** 02111

**Location 2:**

**City:** Henderson

**Country:** United States

**Facility:** Brown Hand Center and Achilles Foot & Ankle Specialist

**State:** Nevada

**Zip:** 89052

**Location 3:**

**City:** Houston

**Country:** United States

**Facility:** Advanced Diagnostic Foot and Ankle Specialist of Cy-Fair

**State:** Texas

**Zip:** 77095

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009135

- Term: Muscular Diseases

- ID: D000005531

- Term: Foot Deformities, Acquired

- ID: D000005530

- Term: Foot Deformities

- ID: D000018409

- Term: Foot Injuries

- ID: D000007869

- Term: Leg Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M6510

- Name: Contracture

- Relevance: HIGH

- As Found: Contracture

- ID: M22606

- Name: Hallux Rigidus

- Relevance: HIGH

- As Found: Hallux Limitus

- ID: M22604

- Name: Hallux Limitus

- Relevance: HIGH

- As Found: Hallux Limitus

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M8654

- Name: Foot Deformities

- Relevance: LOW

- As Found: Unknown

- ID: M8656

- Name: Foot Deformities, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M8655

- Name: Foot Deformities, Acquired

- Relevance: LOW

- As Found: Unknown

- ID: M20528

- Name: Foot Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003286

- Term: Contracture

- ID: D000020857

- Term: Hallux Limitus

- ID: D000020859

- Term: Hallux Rigidus

### Misc Info Module

- Version Holder: 2024-05-24
