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Secur-Fit Advanced Outcomes Study
NA trial testing Secur-Fit Advanced Hip Stem in Arthroplasty, Replacement, Hip in 326 participants. Terminated before completion.
| Lead sponsor | Stryker Orthopaedics |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 326 |
| Start date | 15 August 2013 |
| Primary completion | 1 May 2023 |
| Estimated completion | 13 June 2024 |
| Sites | 8 locations across United States |
Stryker Orthopaedics — full company profile →
Adults 21 to 75, any sex, with Arthroplasty, Replacement, Hip. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary objective is to determine the success rate at 5 years postoperative with the Secur-Fit Advanced Hip Stem in the cementless application. Success is defined as absence of femoral stem revision and/or removal for aseptic loosening or device-related femoral fracture at 5 years postoperative.
| Group | Value | 95% CI |
|---|---|---|
| Secur-Fit Advanced | 0 |
To evaluate all-cause revision and removal rates with the Secur-Fit Advanced Hip Stem and compare with those reported for other primary hip stems in the literature.
| Group | Value | 95% CI |
|---|---|---|
| Secur-Fit Advanced | 6 |
To evaluate rate of device-related femoral fracture among patients implanted with the Secur-Fit Advanced Hip Stem within 30 days postoperative, and compare with rates reported for other primary hip stems in the literature.
| Group | Value | 95% CI |
|---|---|---|
| Secur-Fit Advanced | 1 |
To demonstrate the close relationship between the seating height of the Secur-Fit Advanced Hip Stem and its associated femoral broach by intraoperatively measuring the component exposure or countersink upon final seating.
| Group | Value | 95% CI |
|---|---|---|
| Secur-Fit Advanced | 223 |
| Group | Value | 95% CI |
|---|---|---|
| Secur-Fit Advanced | 82 |
| Group | Value | 95% CI |
|---|---|---|
| Secur-Fit Advanced | 9 |
Time frame: The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Operative Site Events | Non Operative Site Events … |
|---|---|---|---|
| Femoral Fracture | Injury, poisoning and procedural complications | — | — |
| Systemic Other | Blood and lymphatic system disorders | — | — |
| Superficial Wound Infection | Infections and infestations | — | — |
| Femoral Crack | Injury, poisoning and procedural complications | — | — |
| Urogenital | Renal and urinary disorders | — | — |
| Systemic Other | Surgical and medical procedures | — | — |
| Deep Joint Infection | Infections and infestations | — | — |
| Dislocation | Musculoskeletal and connective tissue disorders | — | — |
| Femoral Component Subsidence | Musculoskeletal and connective tissue disorders | — | — |
| Femoral Fracture | Musculoskeletal and connective tissue disorders | — | — |
| Tendonitis | Musculoskeletal and connective tissue disorders | — | — |
| Operative Site Other | Injury, poisoning and procedural complications | — | — |
| Operative Site Other | Surgical and medical procedures | — | — |
| Reaction | System | Operative Site Events | Non Operative Site Events … |
|---|---|---|---|
| Bursitis | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Femoral Fracture, Systemic Other, Superficial Wound Infection, Femoral Crack, Urogenital, Systemic Other, Deep Joint Infection, Dislocation.
Data from ClinicalTrials.gov NCT01917929 adverse events section.
The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.
No peer-reviewed publications indexed yet for this trial.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01917929.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing