Trial Outcomes & Findings for Clinical Outcomes Study Evaluating the Zero-P PEEK (NCT NCT00945243)

NCT ID: NCT00945243

Last Updated: 2017-11-06

Results Overview

Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2017-11-06

Participant Flow

Participant milestones

Measure	Treatment Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

Treatment Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.

Overall Study Study Terminated: Subjects Dispositioned

3

Baseline Characteristics

Clinical Outcomes Study Evaluating the Zero-P PEEK

Baseline characteristics by cohort

Measure	Treatment n=11 Participants Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
Age, Continuous	47.8 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 8 subjects had data at 24 months

Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.

Outcome measures

Measure

Treatment n=8 Participants Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.

Assessment of Neck Disability Index Scores

87.5 percentage of subjects

SECONDARY outcome

Timeframe: 24 months

Population: 8 subjects had data at 24 months.

Percentage of subjects who experienced a maintenance of improvement in VAS neck pain intensity, neck pain frequency, arm pain intensity, and/or arm pain frequency.

Outcome measures

Measure

Treatment n=8 Participants Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.

Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)

75.0 percentage of subjects

SECONDARY outcome

Timeframe: 24 months

Population: 11 subjects were enrolled and treated on protocol and were thus considered for safety information

Percentage of subjects who had an implant related complication

Outcome measures

Measure

Treatment n=11 Participants Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.

Implant Related Complications

0 percentage of subjects

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=11 participants at risk Treatment of cervical DDD with the Zero-P device ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
Nervous system disorders Pain and/or Weakness	27.3% 3/11 • Number of events 3 • From enrollment out to 24 months
Nervous system disorders Seizure	9.1% 1/11 • Number of events 1 • From enrollment out to 24 months
Immune system disorders Cold Symptoms	9.1% 1/11 • Number of events 1 • From enrollment out to 24 months
Surgical and medical procedures Adjacent Level Surgery	9.1% 1/11 • Number of events 1 • From enrollment out to 24 months

Additional Information

Mark Lotito

DePuy Synthes Spine

Phone: 508-880-8045

Email: mlotito@its.jnj.com

Results disclosure agreements

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

Restriction type: LTE60