A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive an Exactech Hip System for total hip arthroplasty (THA) prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
Study Type
OBSERVATIONAL
Enrollment
2,946
The Exactech Hip System comprises a fixed-bearing hip joint prostheses used in treating human hip joint diseases as part of THA. These prostheses include a combination of the components and are available in a range of sizes to accommodate varying anatomical requirements.
Tulsa Bone & Joint Associates
Tulsa, Oklahoma, United States
RECRUITINGHarris Hip Score
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Time frame: Preoperative
Harris Hip Score
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Time frame: 4-6 week Post-op; per standard of care
Harris Hip Score
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Time frame: 3-6 month Post-op; per standard of care
Harris Hip Score
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Time frame: Annually up to 10 years; per standard of care
Oxford Hip Score
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Time frame: Preoperative
Oxford Hip Score
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Time frame: 4-6 week Post-op; per standard of care
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oxford Hip Score
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Time frame: 3-6 month Post-op; per standard of care
Oxford Hip Score
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
Time frame: Annually up to 10 years; per standard of care