Trial Outcomes & Findings for Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe (NCT NCT01673347)

Last Updated: 2017-05-23

Results Overview

Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

24 participants

Primary outcome timeframe

5-years postoperative

Results posted on

2017-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	MENISCAL ALLOGRAFT The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. Meniscal Allograft: Meniscal allograft
Overall Study STARTED	24
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	MENISCAL ALLOGRAFT The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. Meniscal Allograft: Meniscal allograft
Overall Study failure of allograft	7

Baseline Characteristics

Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MENISCAL ALLOGRAFT n=24 Participants The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. Meniscal Allograft: Meniscal allograft
Age, Continuous	55 years STANDARD_DEVIATION 7.12 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI	25.27 kg/m2 STANDARD_DEVIATION 4.33 • n=5 Participants

PRIMARY outcome

Timeframe: 5-years postoperative

Population: Study terminated prior to 5-year endpoint, no participants evaluated

Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.

Outcome measures

Outcome measures
Measure	MENISCAL ALLOGRAFT The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
Allograft Stability	0

SECONDARY outcome

Timeframe: 3-months postoperative

Population: 17 participants available to analyze at 3 months due to early allograft failure in 7 participants

Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain

Outcome measures

Outcome measures
Measure	MENISCAL ALLOGRAFT n=17 Participants The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
Pain	2.65 units on a scale Standard Deviation 2.13

SECONDARY outcome

Timeframe: 3-months postoperative

Population: 17 participants available to analyze at 3 months due to early allograft failure in 7 participants

Range of Motion Plantarflexion

Outcome measures

Outcome measures
Measure	MENISCAL ALLOGRAFT n=17 Participants The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
Range of Motion Plantarflexion	20 degrees Standard Deviation 8.13

SECONDARY outcome

Timeframe: 3-months postoperative

Population: 17 participants available to analyze at 3 months due to early allograft failure in 7 participants

Range of Motion Dorsiflexion

Outcome measures

Outcome measures
Measure	MENISCAL ALLOGRAFT n=17 Participants The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
Range of Motion Dorsiflexion	40 degrees Standard Deviation 15.86

Adverse Events

MENISCAL ALLOGRAFT

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MENISCAL ALLOGRAFT n=24 participants at risk The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe. Meniscal Allograft: Meniscal allograft
Musculoskeletal and connective tissue disorders Allograft failure	29.2% 7/24 • Number of events 7 • 5 years postoperative

Additional Information

Erin Baker, PhD

William Beaumont Hospital

Phone: 248-551-1816

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place