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Trial Outcomes & Findings for Comparison of Cervical Laminectomy to Laminoplasty (NCT NCT01324622)

NCT ID: NCT01324622

Last Updated: 2017-12-07

Results Overview

Number of participants who have mJOA Recovery Rate ≥0%. mJOA Recovery Rate is defined as: mJOA Recovery Rate = ((PostOp Score-PreOp Score)/(17 - Pre-Op Score))\*100

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

12 months

Results posted on

2017-12-07

Participant Flow

Participant milestones

Participant milestones
Measure
Laminectomy
Active Comparator: Laminectomy Control, Standard Procedure
Laminoplasty
Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
Overall Study
STARTED
13
11
Overall Study
COMPLETED
4
4
Overall Study
NOT COMPLETED
9
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Laminectomy
Active Comparator: Laminectomy Control, Standard Procedure
Laminoplasty
Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
Overall Study
Lost to Follow-up
7
7
Overall Study
Death
1
0
Overall Study
Lack of Efficacy
1
0

Baseline Characteristics

Comparison of Cervical Laminectomy to Laminoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Laminectomy
n=13 Participants
Active Comparator: Laminectomy Control, Standard Procedure
Laminoplasty
n=11 Participants
Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
Total
n=24 Participants
Total of all reporting groups
Age, Continuous
57 years
STANDARD_DEVIATION 10 • n=5 Participants
59 years
STANDARD_DEVIATION 12 • n=7 Participants
58 years
STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
3 Participants
n=7 Participants
11 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
8 Participants
n=7 Participants
13 Participants
n=5 Participants
Region of Enrollment
United States
13 participants
n=5 Participants
11 participants
n=7 Participants
24 participants
n=5 Participants
BMI
29 kg/m2
STANDARD_DEVIATION 7 • n=5 Participants
30 kg/m2
STANDARD_DEVIATION 4 • n=7 Participants
30 kg/m2
STANDARD_DEVIATION 6 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Number of participants with 12-month follow-up data.

Number of participants who have mJOA Recovery Rate ≥0%. mJOA Recovery Rate is defined as: mJOA Recovery Rate = ((PostOp Score-PreOp Score)/(17 - Pre-Op Score))\*100

Outcome measures

Outcome measures
Measure
Laminectomy
n=10 Participants
Active Comparator: Laminectomy Control, Standard Procedure
Laminoplasty
n=10 Participants
Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate
10 participants with mJOA Recovery Rate ≥0
10 participants with mJOA Recovery Rate ≥0

PRIMARY outcome

Timeframe: 12 months

Population: Number of participants with radiographic data available at 12 month visit

Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph

Outcome measures

Outcome measures
Measure
Laminectomy
n=8 Participants
Active Comparator: Laminectomy Control, Standard Procedure
Laminoplasty
n=5 Participants
Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
Sagittal Angle Success
8 participants with ≤15° sagittal angle
5 participants with ≤15° sagittal angle

PRIMARY outcome

Timeframe: up to 24 months

Success defined as a lack of revision, removal or addition of supplemental fixation.

Outcome measures

Outcome measures
Measure
Laminectomy
n=11 Participants
Active Comparator: Laminectomy Control, Standard Procedure
Laminoplasty
n=13 Participants
Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
Incidence of Surgical Interventions
10 participants w/o surgical intervention
13 participants w/o surgical intervention

SECONDARY outcome

Timeframe: Up to 24 months

Population: Due to the study's early termination, no data were collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Due to the study's early termination, no data were collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Due to the study's early termination, no data were collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Due to the study's early termination, no data were collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Due to the study's early termination, no data were collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Due to the study's early termination, no data were collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Due to the study's early termination, no data were collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Due to the study's early termination, no data were collected for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Due to the study's early termination, no data were collected for this outcome.

Outcome measures

Outcome data not reported

Adverse Events

Laminectomy

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Laminoplasty

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Laminectomy
n=13 participants at risk
Control laminectomy: standard procedure
Laminoplasty
n=11 participants at risk
Treatment group Laminoplasty: Utilizing the ARCH Fixation System (Study device)
Musculoskeletal and connective tissue disorders
Cervical disc herniation
0.00%
0/13 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).
9.1%
1/11 • Number of events 1 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).

Other adverse events

Other adverse events
Measure
Laminectomy
n=13 participants at risk
Control laminectomy: standard procedure
Laminoplasty
n=11 participants at risk
Treatment group Laminoplasty: Utilizing the ARCH Fixation System (Study device)
Renal and urinary disorders
Loss of bladder control
7.7%
1/13 • Number of events 1 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).
0.00%
0/11 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).
Musculoskeletal and connective tissue disorders
Muscle Spasms
0.00%
0/13 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).
9.1%
1/11 • Number of events 1 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).
Musculoskeletal and connective tissue disorders
Muscle weakness/numbness
15.4%
2/13 • Number of events 2 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).
0.00%
0/11 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).
Musculoskeletal and connective tissue disorders
Pain
7.7%
1/13 • Number of events 2 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).
0.00%
0/11 • All complications and/or adverse effects were recorded intra-operatively and at each follow-up interval (6 weeks, 6 months, 12 months and 24 months).

Additional Information

Allyson Morris

DePuy Synthes

Phone: 610-719-5298

Results disclosure agreements

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

Restriction type: LTE60