Trial Outcomes & Findings for Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel (NCT NCT01028300)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

24 months

Results posted on

2016-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	ProDisc L ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	ProDisc L ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
Overall Study Study Terminated	4

Baseline Characteristics

Clinical Outcomes of Lumbar Degenerative Disc Disease in Active-Duty U.S. Service Personnel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ProDisc L n=4 Participants ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.

Outcome measures

Outcome data not reported

Adverse Events

ProDisc L

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ProDisc L n=4 participants at risk ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
Skin and subcutaneous tissue disorders Non-infected seroma	25.0% 1/4 • Number of events 1 • 12 and 24 months

Other adverse events

Other adverse events
Measure	ProDisc L n=4 participants at risk ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
Musculoskeletal and connective tissue disorders Back Pain	25.0% 1/4 • Number of events 1 • 12 and 24 months
Nervous system disorders Paresthesia	25.0% 1/4 • Number of events 1 • 12 and 24 months
Gastrointestinal disorders Emesis	25.0% 1/4 • Number of events 1 • 12 and 24 months
Gastrointestinal disorders Pain-abdomen	25.0% 1/4 • Number of events 1 • 12 and 24 months

Additional Information

Mark Lotito

DePuy Synthes Spine

Phone: 508-880-8045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Clinical Investigators may freely present or publish results of the Clinical Investigation in a manner which fairly sets forth the conclusions reached by the Clinical Investigators, but only after the Sponsor has been given the opportunity of reviewing the proposed presentation or publication prior to the intended submission, presentation, or publication date
Publication restrictions are in place

Restriction type: OTHER