Trial Outcomes & Findings for Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System (NCT NCT04079114)

NCT ID: NCT04079114

Last Updated: 2020-06-30

Results Overview

Represents the implants that survived by counting the number of implants revised.

• Recruitment status: TERMINATED
• Target enrollment: 166 participants
• Primary outcome timeframe: 3 years postoperatively, due to early study termination
• Results posted on: 2020-06-30

Participant Flow

Participant milestones

Measure	Patients Who Received the Stafit Acetabular System Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Overall Study STARTED	166
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	166

Reasons for withdrawal

Measure	Patients Who Received the Stafit Acetabular System Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Overall Study Study prematuely terminated.	166

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients Who Received the Stafit Acetabular System n=166 Participants Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Age, Continuous	73.9 years STANDARD_DEVIATION 7.9 • n=166 Participants
Sex: Female, Male Female	116 Participants n=166 Participants
Sex: Female, Male Male	50 Participants n=166 Participants
Body Mass Index (kg/m2)	27.0 kg/m^2 STANDARD_DEVIATION 5.2 • n=166 Participants

PRIMARY outcome

Timeframe: 3 years postoperatively, due to early study termination

Population: Outcome Measure Data at 3 years postoperative (Study early terminated). The Kaplan-Meier survival rate with cup revision for any reason.

Represents the implants that survived by counting the number of implants revised.

Outcome measures

Measure	Patients Who Received the Stafit Acetabular System n=82 Implants Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Implant Survival	100 percentage of implant survival

PRIMARY outcome

Timeframe: 2 years

Population: Count of the number of dislocations 2 years postoperatively.

Assessed by counting the number of implant dislocations

Outcome measures

Measure	Patients Who Received the Stafit Acetabular System n=166 implants Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Dislocation Rate	0 Implant Dislocations

SECONDARY outcome

Timeframe: 3 years postoperatively, due to early study termination

Population: Outcome Measure Data at 3 years postoperative (Study early terminated). Number Of Unilateral Participants: 48 Unilaterals; Number Of Bilateral Participants : 1

The Harris Hip Score is a questionnaire filled by the surgeon on the patients who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication.

The function domain consists of daily activities (stairs, public transportation, sitting, and managing shoes and socks) and gait (limp, support needed for walking, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction.

There are 10 items. The score has a minimum of 0 (worst possible score) to a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).

Outcome measures

Measure	Patients Who Received the Stafit Acetabular System n=50 Implants Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Evaluation of Pain and Functional Performance Determined by the Harris Hip Score	91.5 score on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: 3 years postoperatively, due to early study termination

Population: Outcome Measure Data at 3 years postoperative (Study early terminated). Record of any adverse events related to the Stafit Acetabular System.

Reported number of patients with adverse events related to the implant. Adverse events include: dislocations of the hip, revisions and removals of the implants

Outcome measures

Measure	Patients Who Received the Stafit Acetabular System n=166 Participants Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Confirmation of Safety Based on Complications	1 study patients

Adverse Events

Patients Who Received the Stafit Acetabular System

Serious events: 10 serious events

Other events: 11 other events

Deaths: 6 deaths

Serious adverse events

Measure	Patients Who Received the Stafit Acetabular System n=166 participants at risk Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Surgical and medical procedures Femoral Implant Fracture	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Blood and lymphatic system disorders Death (Stroke)	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
General disorders Death	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Infections and infestations Infection	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Infections and infestations Deep Infection <6 Weeks	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).

Other adverse events

Measure	Patients Who Received the Stafit Acetabular System n=166 participants at risk Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
Infections and infestations Deep Infection <6 Weeks	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Blood and lymphatic system disorders Stroke	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Surgical and medical procedures Peroperative fracture of the femur	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Vascular disorders Vascular Injury	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Surgical and medical procedures Fracture femur	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Musculoskeletal and connective tissue disorders Pseudoarthrosis	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Infections and infestations Suspicion infection	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Nervous system disorders Axonal mononeuropathy	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Surgical and medical procedures Total Knee Arthroplasty Left	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Social circumstances Fall	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Surgical and medical procedures Fracture of Trochanter	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Blood and lymphatic system disorders Haematoma	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Cardiac disorders Cardiac Arrhythmia	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).
Blood and lymphatic system disorders Transfusion Reaction	0.60% 1/166 • follow-up visits at 6-12 weeks, 1, 2, and up to 3 years postoperatively. List of all the adverse events reported until the early study termination (some patients came until 3 year follow-up).

Additional Information

Emilie Rohmer, Clinical Operations Manager

Zimmer Biomet

Phone: +41 58 85 48210

Email: Emilie.Rohmer@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place