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Study closed after the 5 year end-point was reached after a review of the status further to a request from the investigators to discontinue participation.
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The purpose of this study is to monitor the performance of the Summitâ„¢ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Summit Tapered Hip System | Other | A cementless, tapered femoral component for use in total hip replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Summit Tapered Hip System | Device | A cementless, tapered femoral component for use in total hip replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier survivorship calculated at the five-year time point | 5yrs post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier survivorship calculations | Annually | |
| Harris Hip score | 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery | |
| Oxford score |
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Inclusion Criteria:
i) Male or female subjects, aged between 18 and 70 years (inclusive).
ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
iv) Subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem.
Exclusion Criteria:
i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
ii) Subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty.
iii) Women who are pregnant.
iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
vi) Subjects who are currently involved in any injury litigation claims.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2. Ruijin Hospital | Shanghai | China | ||||
| 3. The University of Hong Kong at Queen Mary Hospital |
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| 6mths and Annually post-surgery |
| UCLA activity rating | 6mths and Annually post-surgery |
| Thigh pain analysis | 6mths and Annually post-surgery |
| Radiological analysis | pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery |
| Pokfulam |
| Hong Kong |
| 1. Ospedale Riuniti Di Bergamo | Bergamo | Italy |
| 5. Middlemore Hospital | Auckland | New Zealand |
| 4. Yonsei University College of Medicine | Seoul | South Korea |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| D003095 | Collagen Diseases |
| D010020 | Osteonecrosis |
| D006618 | Hip Dislocation, Congenital |
| D060048 | Slipped Capital Femoral Epiphyses |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D004839 | Epiphyses, Slipped |
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