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The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the SMF S&E study.
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This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.
The objectives of this study are to evaluate the safety and efficacy of the study device. This study will document any device-related, surgical or post-operative complication and adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems. Outcome measures will be quantified through statistical analysis of study device , HOOS questionnaire, radiographic assessments, Harris Hip Score, and adverse event reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMF mini-stem hip replacement recipient | Received the device via total hip arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip arthroplasty | Device | Total hip arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision of the study device | Instances of required revision of the study device | Discharge through 10 years |
| Device related Adverse Events | surgical, device-related, death and serious adverse events will be analyzed | Implant through 10 years |
| Harris Hip Score | Questionnaire to calculate pain, walking abilities, activities, degrees of hip motion | Baseline through 10 years |
| HOOS Questionnaire | Questionnaire to calculate hip symptoms, stiffness, pain, function and quality of life | Baseline through 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring total hip replacement.
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| Name | Affiliation | Role |
|---|---|---|
| Sobia Parveen | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middleheim | Berchem | 2600 | Belgium | |||
| St. Michael's Hospital |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Toronto |
| Ontario |
| M5C1R6 |
| Canada |
| Hopital Maisonneuve Rosemont, Hmr | Montreal | Quebec | 5701 | Canada |
| CHUQ-L'Hôtel-Dieu de Québec | Québec | Quebec | G1R 2J6 | Canada |
| St. Vincenz Hospital | Brakel | 22024 | Germany |
| Brüderkrankenhaus St. Josef | Paderborn | 33098 | Germany |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |