Trial Outcomes & Findings for IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee. (NCT NCT02037204)

Results Overview

Adverse events rate

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

35 participants

Primary outcome timeframe

18 months

Results posted on

2019-01-02

Participant Flow

Patient recruitment started on February 1st 2013 and was completed in September 2014

Four patients were excluded based on MRI scans showing multiple cartilage defects and/ or osteochondral defects. Inclusion was continued until n = 35 was reached

Participant milestones

Participant milestones
Measure	Cartilage Repair Surgery All 35 patients received a single-stage cartilage repair treatment using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cartilage Repair Surgery n=35 Participants Single-stage cartilage repair surgery using autologous chondrons and allogeneic MSCs in a fibrin glue carrier. Cartilage repair surgery: Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants
Age, Continuous	33 years STANDARD_DEVIATION 8 • n=39 Participants
Sex: Female, Male Female	11 Participants n=39 Participants
Sex: Female, Male Male	24 Participants n=39 Participants
Region of Enrollment Netherlands	35 participants n=39 Participants

PRIMARY outcome

Timeframe: 18 months

Population: All patients were monitored for the duration of the studie for inflammation and signs of a foreign body response by an independent physician using standardized clinical measures, pain assessment by numeric rating scale for pain and blood analysis including serum C-reactive protein, erythrocyte sedimentation rate and leukocyte count.

Adverse events rate

Outcome measures

Outcome measures
Measure	Cartilage Repair Surgery n=35 Participants Single-stage cartilage repair surgery in 35 patients, using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
Safety: Adverse Events	0 participants

SECONDARY outcome

Timeframe: 3 and 18 months

Population: Differences in clinical outcome between baseline and 3 and 12 months after surgery were tested by a repeated measures analysis of variance (ANOVA).

Clinical improvement as measured by patient reported outcome scores. The questionnaire has been developed to evaluate the symptoms and limitations for patients with osteoarthritis. The outcome of the KOOS-scale varies from 0-100, where 0 indicates the greatest possible problems and is the worst outcome and 100 indicates no problems.

Outcome measures

Outcome measures
Measure	Cartilage Repair Surgery n=35 Participants Single-stage cartilage repair surgery in 35 patients, using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score KOOS outcome baseline	57.9 units on a scale Standard Deviation 16.1
Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score KOOS outcome 3 months	76.6 units on a scale Standard Deviation 11.1
Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score KOOS outcome 18 months	85.4 units on a scale Standard Deviation 13.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.

Outcome measures

Outcome data not reported

Adverse Events

Cartilage Repair Surgery

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cartilage Repair Surgery n=35 participants at risk All 35 patients received a single-stage cartilage repair treatment using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
Musculoskeletal and connective tissue disorders Post surgery (joint swelling, pain)	51.4% 18/35 • Number of events 25 • All patients were monitored for the duration of 18 months after surgery, at fixed time points (at 7 days, 6 weeks and 3,6,12 and 18 months after surgery), for inflammation and signs of a foreign body response by an independent physician (rheumatologist) using standardized clinical measures, pain assessment by numeric rating scale for pain and blood analysis including serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and leukocyte count.

Additional Information

Prof. Daniel Saris

UMC Utrecht

Phone: 000000000000000000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place