Dysplasia Coxarthrosis Clinical Trial
Official title:
Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study
| NCT number | NCT04172129 |
| Other study ID # | R11014-3-D |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 26, 2011 |
| Est. completion date | February 15, 2017 |
| Verified date | November 2019 |
| Source | Smith & Nephew, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith & Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | February 15, 2017 |
| Est. primary completion date | January 4, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required. - Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations. - Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function. - Subject was 30 to 65 (inclusive) years of age at time of surgery. Exclusion Criteria: - Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery. - Subject had a local or systemic infection. - Subject had previously diagnosed osteoporosis. - Subject had a femoral neck angle of >145°. - Subject had a femoral neck angle of <125°. - Subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (American Society of Anaesthesiologists' (ASA) Score 3 or 4). - Subject had a documented allergy against elements of the implanted device. - Subject had a neurological disease with changed motor function. - Subject was pregnant. - Subject had a Body Mass Index (BMI) > 30. - Subject suffered from alcoholism or addictive disorders. - Subject needed a revision hip arthroplasty. - Subject had an insufficient command of the language to understand patient information and consent. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Orthopädische Klinik der Medizinischen Hochschule Hannover | Hannover |
| Lead Sponsor | Collaborator |
|---|---|
| Smith & Nephew Orthopaedics AG |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of migration pattern of the Nanos stem | Measuring migration used the model-based RSA method | 2 years | |
| Primary | Change in quality of life | Measuring change in quality of life using the Short Form (SF) 36 Mental Component Score Minimum Value: 0 (worst outcome) Maximum Value: 100 (best outcome) |
2 years | |
| Secondary | Harris Hip Score | Investigator assessed outcome score Minimum: 0 (worst outcome) Maximum: 100 (best outcome) | 2 years | |
| Secondary | University of California, Los Angeles (UCLA) scale | Score rating the patient's current activity level Minimum: 1 (wholly inactive subject) Maximum: 10 (totally active subject) |
2 years | |
| Secondary | Pain Visual Analogue Scale | Score representing patient's current pain intensity Minimum: 0 (no pain) Maximum: 100 (very severe pain) |
2 years | |
| Secondary | Postel Merle d'Aubigné-Score | Score grading the functional value of the hip Minimum: 0 (worst outcome) Maximum: 6 ( best outcome) Grading is done in each of the three dimensions: pain, mobility and ability to walk. |
2 years | |
| Secondary | Hip Disability and Ostheoarthritis Outcome Score | Patient reported outcome Minimum: 0 (best outcome) Maximum: 96 (worst outcome) |
2 years | |
| Secondary | Radiographic Evaluation | Evaluation of radiographic images regarding implant position, implant fixation, heterotopic ossifications (HO), radiolucencies, osteolysis, atrophy and hypertrophy | 2 years | |
| Secondary | Number of adverse events | Collection of adverse events | 2 years |