PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03672370|
Recruitment Status : Terminated (Study terminated as CE marks of the devices used have not been renewed.)
First Posted : September 14, 2018
Results First Posted : January 14, 2021
Last Update Posted : January 14, 2021
|Condition or disease|
|Avascular Necrosis Osteoarthritis Inflammatory Arthritis Posttraumatic Arthritis|
The objectives of this study are to obtain survival and outcomes data on the Alloclassic® Variall® Cup in combination with the BIOLOX® delta Taper Liner and a BIOLOX® delta Femoral Head used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records.
Two sites are involved in this study, enrolling a total of 100 patients for the study. All subjects were required to participate in the Informed Consent Process.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip Arthroplasty A Multi-center, Prospective, Non-controlled Post Market Surveillance Study|
|Actual Study Start Date :||March 24, 2015|
|Actual Primary Completion Date :||May 14, 2019|
|Actual Study Completion Date :||May 1, 2020|
Alloclassic® Variall® Cup
Subjects who received the Alloclassic® Variall® Cup Ceramic Bearing System
- Clinical Success Will be Based on the Harris Hip Scoring System [ Time Frame: 3 years ]
The Harris Hip Score (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 points and a maximum of 100 points.
Clinical success will be defined as a modified Harris Hip score of > 80 that included a rating of 'mild', or 'no pain'; a failure will be defined as a modified Harris Hip score < 80.
- Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate [ Time Frame: 4 years ]Endpoint revision of any investigational device for any reason attributable to any investigational device
- Oxford Hip Score [ Time Frame: 3 years ]
The purpose of the Oxford Hip Score (OHS) is to assess the outcome after total hip arthroplasty by measuring cases' perceptions in adjunction to surgery. The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc.
The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score
- EQ-5D [ Time Frame: 3 years ]
The EQ-5D questionnaire comprises two parts. For the first part, respondents are asked to tick boxes to indicate the level of problem on each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In total, there are three levels per dimension (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Responses are coded as single-digit numbers expressing the severity level selected in each dimension. The digits for the five dimensions are combined in a 5-digit code.
The second part of the questionnaire is the EQ Visual Analogue Scale. This captures the respondent's overall assessment of their health from 0 (worst health imaginable) to 100 (best health imaginable).
The results from both parts are indexed, weightened and pulled together. The final score lies between 1 for full health and 0 for death. Values less than 0 are possible considered to be worse than death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672370
|Wien, Austria, 1030|
|Orthopädisches Spital Speising GmbH|
|Wien, Austria, 1130|
|Study Director:||Hassan Achakri||Zimmer Biomet|