NCT04209426: SYMCOR-2

Retrospective Observational Cohort Study of SYMBOL CUP DM 2

Completed Results posted Last updated 18 April 2025

What this trial tests

trial testing THA with SYMBOL CUP DMR HA in Revision Total Hip Arthroplasty in 20 participants. Completed in 14 August 2018.

Timeline

18 March 2015

Primary endpoint
31 March 2018

14 August 2018

Quick facts

Lead sponsor	Dedienne Sante S.A.S.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20
Start date	18 March 2015
Primary completion	31 March 2018
Estimated completion	14 August 2018
Sites	1 location across France

Drugs / interventions tested

• THA with SYMBOL CUP DMR HA
• THA with SYMBOL CUP DM CEM

Conditions studied

• Revision Total Hip Arthroplasty — all drugs for Revision Total Hip Arthroplasty →
• Primary Total Hip Arthroplasty — all drugs for Primary Total Hip Arthroplasty →

Sponsor

Dedienne Sante S.A.S.

Who can join

18 and older, any sex, with Revision Total Hip Arthroplasty or Primary Total Hip Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Implant Survival: Acetabular Cup Survival at 2-year Follow-up Primary · 2 years as of index operation

This is a the ratio of the number of patient joints surviving with the acetabular prosthesis in position at a given follow-up time (numerator) over the initial number of those joints from the date they received the acetabular prosthesis (denominator). The cumulative ratio is recalculated at each event using the Kaplan-Meier method from the date of each joint index operation through the date of each participant's death or prosthetic removal surgery or loss-to-follow-up or last assessment alive with the acetabular prosthesis in place. The longest duration between the index operation and the fina

Group	Value	95% CI
HMB-DMR-HA	94.7	68.1 – 99.2
HMB-DM-CEM	100	100 – 100

Number of Patients With One or Several Post-operative Adverse Events and Count of Each Serious Adverse Event and Aggregate Count of Adverse Events Secondary · 2 years as of index operation

All serious post-operative adverse events are taken into account including implant dislocation, infections, revision surgery.

Group	Value	95% CI
HMB-DMR-HA	10
HMB-DM-CEM	0

Harris Hip Score (HHS) at Baseline and 1-year Follow-up Secondary · 1 year as of index operation

Harris Hip Score (HHS) is measured at each assessment in each patient. HHS is a physician-completed instrument that consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 0-4 points), and range of motion (2 items, 0-5 points). Scores range from 0 (worse disability) to 100 (less disability). The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments

HHS preoperative

Group	Value	95% CI
HMB-DMR-HA	34	± 37.7
HMB-DM-CEM	58	± 13.8

HHS 1-year

Group	Value	95% CI
HMB-DMR-HA	89	± 24
HMB-DM-CEM	86	± 34.2

The Modified Harris Hip Score (Modified HHS) at Baseline, 1-year and 2-year Follow-up Secondary · 2 years as of index operation

The modified Harris Hip Score (modified HHS) is the sum of pain subscore and functional subscore of the Harris Hip Score. It consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points). Scores range from 0 (worse disability) to 91 (less disability)The score is measured at each assessment in each patient. The mean and confidence interval of the score is measured at each assessment as well as for the within-patient difference between assessments

mHHS preoperative

Group	Value	95% CI
HMB-DMR-HA	29	± 21.5
HMB-DM-CEM	49	± 13.4

mHHS 1-year

Group	Value	95% CI
HMB-DMR-HA	80	± 22.5
HMB-DM-CEM	77	± 34.2

mHHS 2-year

Group	Value	95% CI
HMB-DMR-HA	87	± 11.3
HMB-DM-CEM	80	± 10.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Collection of all side-effects occurring between surgery (prosthesis insertion) and the last clinical follow-up (2-year follow-up at least). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HMB-DMR-HA

Serious: 7/15 (47%)

Deaths: 3/15

HMB-DM-CEM

Serious: 0/5 (0%)

Deaths: 0/5

Serious adverse events (4 terms)

Reaction	System	HMB-DMR-HA	HMB-DM-CEM
Other	General disorders	—	—
Surgical infection	Surgical and medical procedures	—	—
Intra-prosthetic dislocation	Product Issues	—	—
fall and fracture of the operated area (Vancouver class: A)	Surgical and medical procedures	—	—

Most-reported serious reactions: Other, Surgical infection, Intra-prosthetic dislocation, fall and fracture of the operated area (Vancouver class: A).

Data from ClinicalTrials.gov NCT04209426 adverse events section.

Sponsor's own description

This is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty (THA) with a SYMBOL CUP DMR HA or a SYMBOL CUP DM CEM hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of those two implants at two-year follow-up.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and Efficacy of Hemispherical with Flattened Pole Dual-Mobility Acetabular Cup in Revision or Complex Hip Arthroplasty: The SYMCOR-2 study
   Estour G, Bonin N, Loïc S, Guyen O, et al · · 2020 · DOI 10.21203/rs.3.rs-97244/v1
2. Safety and Efficacy of Hemispherical with Flattened Pole Dual-Mobility Acetabular Cup in Revision or Complex Hip Arthroplasty: The SYMCOR-2 study
   Estour G, Bonin N, Loïc S, Guyen O, et al · · 2020 · DOI 10.21203/rs.3.rs-23636/v1