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Sponsoring company declared bankrupty
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| Name | Class |
|---|---|
| Artimplant AB | INDUSTRY |
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The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg and foot function, pain and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artelon | Experimental | This is an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artelon | Device | Artelon Tissue Reinforcement |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability | 3 months | |
| The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability | 6 months | |
| The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot | 3 months | |
| General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terrence M Philbin, DO | Orthopedic Foot and Ankle Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Foot and Ankle Center | Westerville | Ohio | 43082 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Artelon | This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement. Artelon: Artelon Tissue Reinforcement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Artelon | This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement. Artelon: Artelon Tissue Reinforcement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Artelon | This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement. Artelon: Artelon Tissue Reinforcement |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Immune system disorders |
The sample size is small due to the study being terminated early because of sponsor bankrupty,
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terrence M. Philbin, DO | Orthopedic Foot and Ankle Center | 614-895-8747 | 111 | ofacresearch@orthofootankle.com |
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| ID | Term |
|---|---|
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Range of Motion, Strength and Calf Circumference | 3 months |
| Subjective Evaluation of Treatment | 3 months |
| Return to Work and Previous Physical Activities | 3 months |
| Clinical Evaluation Including Adverse Events | 3 months |
| The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot | 6 months |
| General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire | 6 months |
| Range of Motion, Strength and Calf Circumference | 6 months |
| Subjective Evaluation of Treatment | 6 months |
| Return to Work and Previous Physical Activities | 6 months |
| Clinical Evaluation Including Adverse Events | 6 months |
| The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot | 12 months |
| General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire | 12 months |
| Range of Motion, Strength and Calf Circumference | 12 months |
| Subjective Evaluation of Treatment | 12 months |
| Return to Work and Previous Physical Activities | 12 months |
| Clinical Evaluation Including Adverse Events | 12 months |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 6 months |
|
|
| Primary | The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 12 months |
|
|
| Secondary | The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 3 months |
|
|
| Secondary | General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 3 months |
|
|
| Secondary | Range of Motion, Strength and Calf Circumference | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 3 months |
|
|
| Secondary | Subjective Evaluation of Treatment | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 3 months |
|
|
| Secondary | Return to Work and Previous Physical Activities | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 3 months |
|
|
| Secondary | Clinical Evaluation Including Adverse Events | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 3 months |
|
|
| Secondary | The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 6 months |
|
|
| Secondary | General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 6 months |
|
|
| Secondary | Range of Motion, Strength and Calf Circumference | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 6 months |
|
|
| Secondary | Subjective Evaluation of Treatment | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 6 months |
|
|
| Secondary | Return to Work and Previous Physical Activities | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 6 months |
|
|
| Secondary | Clinical Evaluation Including Adverse Events | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 6 months |
|
|
| Secondary | The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 12 months |
|
|
| Secondary | General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 12 months |
|
|
| Secondary | Range of Motion, Strength and Calf Circumference | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 12 months |
|
|
| Secondary | Subjective Evaluation of Treatment | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 12 months |
|
|
| Secondary | Return to Work and Previous Physical Activities | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 12 months |
|
|
| Secondary | Clinical Evaluation Including Adverse Events | Data not analyzed as study was terminated due to sponsor bankruptcy. | Posted | 12 months |
|
|
| 0 |
| 4 |
| 2 |
| 4 |
| C-difficile | Gastrointestinal disorders |
|
| Influenza | Respiratory, thoracic and mediastinal disorders |
|
| Increased tenderness over left peroneal and posterior tibial tendons | Musculoskeletal and connective tissue disorders |
|
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