Trial Outcomes & Findings for Humeral Shaft Pseudoarthrosis Treated With Bone Autograft Versus Platelet Rich Plasma (NCT NCT02520089)

Results Overview

The evaluation of the radiographic extent of the bony callus (consolidation grade) will be assessed via anteroposterior and lateral radiograph of the arm and classified in different levels, as follows: * Grade 0, no identifiable bony callus . * Grade 1, primary bony callus formation with little or no new periosteal bone. * Grade 2, new periosteal bone formation on two sides of the humerus. * Grade 3, new periosteal bone formation on three or four sides of the humerus.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

9th month

Results posted on

2018-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Bone Autograft The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates. bone autograft of iliac crest: The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties	Platelet Rich Plasma Plus Bone Autograft Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest. Platelet Rich Plasma plus bone autograft: Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis
Overall Study STARTED	12	11
Overall Study COMPLETED	9	7
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Bone Autograft The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates. bone autograft of iliac crest: The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties	Platelet Rich Plasma Plus Bone Autograft Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest. Platelet Rich Plasma plus bone autograft: Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis
Overall Study Lost to Follow-up	3	4

Baseline Characteristics

Humeral Shaft Pseudoarthrosis Treated With Bone Autograft Versus Platelet Rich Plasma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bone Autograft n=9 Participants The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates. bone autograft of iliac crest: The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties	Platelet Rich Plasma Plus Bone Autograft n=7 Participants Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest. Platelet Rich Plasma plus bone autograft: Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.8 years STANDARD_DEVIATION 15.3 • n=5 Participants	37.1 years STANDARD_DEVIATION 10.2 • n=7 Participants	38.1 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Mexico	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9th month

The evaluation of the radiographic extent of the bony callus (consolidation grade) will be assessed via anteroposterior and lateral radiograph of the arm and classified in different levels, as follows: * Grade 0, no identifiable bony callus . * Grade 1, primary bony callus formation with little or no new periosteal bone. * Grade 2, new periosteal bone formation on two sides of the humerus. * Grade 3, new periosteal bone formation on three or four sides of the humerus.

Outcome measures

Outcome measures
Measure	Bone Autograft n=9 Participants The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates. bone autograft of iliac crest: The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties	Platelet Rich Plasma Plus Bone Autograft n=7 Participants Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest. Platelet Rich Plasma plus bone autograft: Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis
Stans Scale	2.7 units on a scale Standard Deviation 0.5	3.0 units on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: 9th months

It is designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Where the better evaluation is equal to 0, and the worst evaluation is equal to 100.

Outcome measures

Outcome measures
Measure	Bone Autograft n=9 Participants The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates. bone autograft of iliac crest: The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties	Platelet Rich Plasma Plus Bone Autograft n=7 Participants Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest. Platelet Rich Plasma plus bone autograft: Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis
Quick Disability of Arm, Shoulder and Hand	7.28 units on a scale Standard Deviation 11.3	5.32 units on a scale Standard Deviation 8.23

Adverse Events

Bone Autograft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Platelet Rich Plasma Plus Bone Autograft

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

Dr. Carlos Alberto Acosta-Olivo

Universidad Autonoma de Nuevo Leon

Phone: +528183476698

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place