An observational study in Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis and Hip Arthritis, sponsored by Dedienne Sante S.A.S.. Recruiting at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Dedienne Sante S.A.S. · Observational
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Among 38 studies in Osteoarthritis, Hip with a site in France — 10 open to participants now, 16 under way, none of them phase 3. Osteoarthritis, Hip · France.
Among the 38 studies in Osteoarthritis, Hip with a site in France, this one is the 3rd largest by planned enrollment of the 17 observational ones that give a count, is one of 7 that started in 2021, is one of 17 observational ones, reaches primary completion later than 14 of the 15 other live ones, and was the 26th registered.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
Browse Osteoarthritis, Hip studies →10 of the 38 studies in Osteoarthritis, Hip with a site in France are open now. Recruiting first, the newest first:
University Hospital, Strasbourg, France · Sites in France
Ages 18+
Medacta International SA · Sites in France
Ages 18–85
Aptissen SA · Sites in France
Ages 18+
University Hospital, Lille · Sites in France
Ages 18+
Lille Catholic University · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 87 Osteoarthritis, Hip studies recruiting now, 54 (62%) set no upper age limit and 7 (8%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 7 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 747 is above the median of 135 across 158 observational studies indexed under Osteoarthritis, Hip.
Median enrollment 130 across the 20 interventional studies, 250 across the 17 observational. Of the 15 that completed or were terminated, 3 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 38 have an industry lead sponsor. The 10 most frequent:
Dedienne Sante S.A.S. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Dedienne Sante S.A.S. has 1 study filed under Osteoarthritis, Hip — fewer than ten, so there is no comparison to draw.
3 of the studies in Osteoarthritis, Hip with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03372278Zimmer BiometPMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty | 2027-01 |
| NCT05829733Aptissen SA6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis | 2027-04 |
| NCT06258369Lille Catholic UniversityGait Initiation and Transition From Double to Single Support in Patients With Unilateral Primary Coxarthrosis | 2027-08-19 |
Add all 3 to your calendar (.ics) → With an account.
Among the 38 studies in Osteoarthritis, Hip with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.
Patient requiring total hip arthroplasty
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients undergoing total hip arthroplasty with at least one medical device from the SYMBOL range
Device: Total hip arthroplasty (primary or revision)
Total hip arthroplasty with at least one medical device from the SYMBOL range
Survivorship of 13 individual SYMBOL orthopaedic components
The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
Time frame: 10 years post-operative
Survivorship of all individual SYMBOL orthopaedic components
The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
Time frame: 6 months, 18 months and 5 years post-operative
Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant.
The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
Time frame: 10 years post-operative
Survivorship of the SYMBOL implants by component assembly (acetabular + femoral components)
The survival rate of a combinaison of implant (acetabular + femoral component) will be calculated on the basis of the first occurrence of implant revision from any cause.
Time frame: Through study completion, an average of 10 years
Adverse Device Effects.
All adverse device effects occurring from the time of subject enrollment until study termination or study completion including intra-operative adverse events. Note: This outcome will also be used for subgroup analyses by component association.
Time frame: Through study completion, an average of 10 years
Radiographic assessment - Implant subsidence.
Stem subsidence will be classified based on the following: * Stem subsidence \< 3mm * Stem subsidence between 3 and 5mm * Stem subsidence \> 5mm Note: This outcome will also be used for subgroup analyses by component association.
Time frame: 6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Osteolysis (granuloma).
Assessment will consider: - Presence or absence of osteolysis. If osteolysis is present, impacted areas will be determined according to DeLee and Charnley or Gruen classification. Note: This outcome will also be used for subgroup analyses by component association.
Time frame: 6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Radiolucent lines.
Assessment will consider: - Presence or absence of radiolucent lines. If radiolucent line is present: * Impacted areas will be determined according to DeLee and Charnley or Gruen classification. * Type of radiolucent lines will be classified based on the following : \< 2mm - regular or \> 2mm - irregular. Note: This outcome will also be used for subgroup analyses by component association.
Time frame: 6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Eterotopic ossifications.
Assessment will consider: - Presence or absence of eterotopic ossifications. If eterotopic ossification, grade will be specified. This outcome will also be measured for subgroup analyses by component association.
Time frame: 6 months, 18 months, 5 and 10 years post-operative
Harris Hip Score (or modified Harris Hip Score) at each visit.
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion. Note: This outcome will also be used for subgroup analyses by component association.
Time frame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
Pain intensity (Numeric Rating Scale)
Numeric Rating scale for pain intensity assessment: * Minimum value: 0 (=no pain) * Maximum value: 10 (= worst possible pain). (Higher scores mean worst outcome). Note: This outcome will also be used for subgroup analyses by component association.
Time frame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
EQ-5D-5L score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale. Note: This outcome will also be used for subgroup analyses by component association.
Time frame: Pre-operative, 18 months, 5 and 10 years post-operative
Global patient satisfaction
Ordinal scale for global patient satisfaction assessment: - Possible values are: not satisfied/quite satisfied/satisfied/very satisfied ("Very satisfied" is the best possible outcome).
Time frame: 18 months post-operative
Hip joint patient satisfaction (Numeric Rating Scale)
Numeric rating scale : Percentage Scale for Hip Joint Patient Satisfaction Assessment. Range of values: from 0 to 100. (100 is the best possible outcome and is equivalent to a normal hip). Note: This outcome will also be used for subgroup analyses by component association.
Time frame: 5 years and10 years post-operative
Not enrolling at this site.
Started Sep 2021 (actual). Primary completion is estimated for Sep 2034, 156 months after the start.
Of 81 observational studies under Osteoarthritis, Hip, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 113. This study's planned 156 months is above that.
How these figures are worked out, and which studies are left out of them.
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Dedienne Sante S.A.S.