Trial Outcomes & Findings for Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF) (NCT NCT01294007)

NCT ID: NCT01294007

Last Updated: 2022-11-02

Results Overview

Number of patients with fusion at the 6- and conditional 12- and 24-month visit

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 6, 12 and 24 month
• Results posted on: 2022-11-02

Participant Flow

Participant milestones

Measure	Patient Enrollment Single patient enrolled for site
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)

Baseline characteristics by cohort

Measure	Study Graft Composite n=1 Participants AlphaGraft ProFuse Demineralized Bone Scaffold are soaked in PureGen according to Preparation for Use and handling technique. The graft composite is placed on the randomized study side contralateral to the autograft bone graft per surgeon's standard technique for PLF. The wound is closed according to surgeon's standard technique. Post operative care will be according to the site specific standard of care. An avoidance of heavy physical activity and limitations on working, lifting, bending etc. are common precautions post procedure. The decision to use a post operative orthosis is left to the discretion of the Investigator. PureGen Osteoprogenitor Cell Allograft: PureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation.	Control Graft Composite Contralateral to the study graft composite, placement of posterolateral fusion graft composite containing iliac crest bone (5 cc/level/side) and local autograft composite (equal volume split with study side). Supplemental posterior pedicle screw fixation utilizing Zodiac, Illico or Xenon Spinal Fixation system. * A defined volume of iliac crest bone graft (indicated in table 2) is harvested and combined with 50% of the previously harvest morselized local bone * The graft composite is placed on the randomized control side using standard technique for PLF Autograft bone: Iliac Crest and Local Autograft Bone	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Continuous	71 years n=5 Participants	—	71 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6, 12 and 24 month

Number of patients with fusion at the 6- and conditional 12- and 24-month visit

Outcome measures

Measure	Patient Enrollment n=1 Participants Single patient enrolled for site
Number of Patients With Fusion	1 Participants

Adverse Events

Patient Enrollment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Saba Pasha, Director Clinical Research & Data Science

ATEC Spine

Phone: 760-356-6639

Email: spasha@atecspine.com

Results disclosure agreements

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