Trial Outcomes & Findings for Clinical Application of BioCleanse Meniscus (NCT NCT00659880)

NCT ID: NCT00659880

Last Updated: 2017-06-26

Results Overview

The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.

• Recruitment status: COMPLETED
• Target enrollment: 9 participants
• Primary outcome timeframe: 60 months
• Results posted on: 2017-06-26

Participant Flow

Participant milestones

Measure	Meniscal Allograft Transplant Patients who received a BioCeanse Meniscal Allograft Transplant
Overall Study STARTED	9
Overall Study 6 Weeks	9
Overall Study 6 Months	9
Overall Study 12 Months	7
Overall Study 24 Months	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Meniscal Allograft Transplant Patients who received a BioCeanse Meniscal Allograft Transplant
Overall Study Lost to Follow-up	5

Baseline Characteristics

Clinical Application of BioCleanse Meniscus

Baseline characteristics by cohort

Measure	Meniscal Allograft Transplant n=9 Participants Patients who received a BioCeanse Meniscal Allograft Transplant
Age, Continuous	31.7 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 months

The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.

Outcome measures

Measure	Meniscal Allograft Transplant n=4 Participants Patients who received a BioCeanse Meniscal Allograft Transplant
Knee Injury and Osteoarthritis Outcome Score (KOOS)	70.1 units on a scale Standard Deviation 33.6

SECONDARY outcome

Timeframe: 12 months

MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn.

Images were also assessed for oedema in each of these 3 regions of the meniscus.

Outcome measures

Measure	Meniscal Allograft Transplant n=4 Participants Patients who received a BioCeanse Meniscal Allograft Transplant
MRI Assessments Integration of Meniscal Body	4 participants
MRI Assessments Integration of Anterior Horn	3 participants
MRI Assessments Integration of Posterior Horn	4 participants
MRI Assessments Mild Edema Anterior Horn	2 participants
MRI Assessments Mild Edema Posterior Horn	1 participants
MRI Assessments Mild Edema Meniscal Body	0 participants

Adverse Events

Meniscal Allograft Transplant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Meniscal Allograft Transplant n=9 participants at risk Patients who received a BioCeanse Meniscal Allograft Transplant
Musculoskeletal and connective tissue disorders Ipsilateral knee pain	11.1% 1/9 • Number of events 1 • Unexpected AE data were collected at each of 5 post-operative visits: 6 weeks, 6 months, 12 months, 24 months, 60 months. All AE were documented on case report forms. Of the AE reported, 2 were definitely not related to the allograft, 2 were considered unlikely related and 2 were considered possibly related.
Musculoskeletal and connective tissue disorders arm fracture	11.1% 1/9 • Number of events 1 • Unexpected AE data were collected at each of 5 post-operative visits: 6 weeks, 6 months, 12 months, 24 months, 60 months. All AE were documented on case report forms. Of the AE reported, 2 were definitely not related to the allograft, 2 were considered unlikely related and 2 were considered possibly related.
Musculoskeletal and connective tissue disorders Knee impinging scar	11.1% 1/9 • Number of events 1 • Unexpected AE data were collected at each of 5 post-operative visits: 6 weeks, 6 months, 12 months, 24 months, 60 months. All AE were documented on case report forms. Of the AE reported, 2 were definitely not related to the allograft, 2 were considered unlikely related and 2 were considered possibly related.
Musculoskeletal and connective tissue disorders Chondrosis: Trochlea & Patella	11.1% 1/9 • Number of events 1 • Unexpected AE data were collected at each of 5 post-operative visits: 6 weeks, 6 months, 12 months, 24 months, 60 months. All AE were documented on case report forms. Of the AE reported, 2 were definitely not related to the allograft, 2 were considered unlikely related and 2 were considered possibly related.
Musculoskeletal and connective tissue disorders meniscal allograft lesion	11.1% 1/9 • Number of events 1 • Unexpected AE data were collected at each of 5 post-operative visits: 6 weeks, 6 months, 12 months, 24 months, 60 months. All AE were documented on case report forms. Of the AE reported, 2 were definitely not related to the allograft, 2 were considered unlikely related and 2 were considered possibly related.
Musculoskeletal and connective tissue disorders Contralateral (non-study) knee pain	11.1% 1/9 • Number of events 1 • Unexpected AE data were collected at each of 5 post-operative visits: 6 weeks, 6 months, 12 months, 24 months, 60 months. All AE were documented on case report forms. Of the AE reported, 2 were definitely not related to the allograft, 2 were considered unlikely related and 2 were considered possibly related.

Additional Information

Robin Waite, RN

RTI Surgical

Phone: 386-418-8888

Email: rwaite@rtix.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI may present/publish in meetings, journals, theses, dissertations the results of Investigation provided that RTI will have been furnished copies of any proposed publication/presentation at least 40 days in advance of the submission. RTI will have 30 days after receipt to object \& withhold consent to the proposed presentation/publication either because there is patentable subject matter which needs protection and or there is Confidential or inaccurate information contained in the publication
• Publication restrictions are in place

Restriction type: OTHER