Trial Outcomes & Findings for Tibial Delayed Healing Pivotal Clinical Trial (NCT NCT01016067)
NCT ID: NCT01016067
Last Updated: 2015-01-21
Results Overview
Overall success is reported as participants who met all of the following criteria: 1. radiographic union success; 2. success in weight bearing ability; 3. improvement in pain at the delayed healing site; 4. no serious adverse event classified as "implant-associated" or "implant/surgical procedure-associated" (device-related); 5.no additional surgical procedures classified as a failure.
TERMINATED
PHASE3
23 participants
12 Months
2015-01-21
Participant Flow
Participant milestones
| Measure |
INFUSE/MASTERGRAFT
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
INFUSE/MASTERGRAFT
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrew due to Relocation
|
0
|
1
|
Baseline Characteristics
Tibial Delayed Healing Pivotal Clinical Trial
Baseline characteristics by cohort
| Measure |
INFUSE/MASTERGRAFT
n=11 Participants
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=12 Participants
Patients received autograft bone with rigid internal fixation.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 8.47 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Height
|
69.0 Inches
STANDARD_DEVIATION 3.44 • n=5 Participants
|
68.6 Inches
STANDARD_DEVIATION 4.56 • n=7 Participants
|
68.8 Inches
STANDARD_DEVIATION 3.98 • n=5 Participants
|
|
Weight
|
178.9 lbs.
STANDARD_DEVIATION 50.07 • n=5 Participants
|
186.3 lbs.
STANDARD_DEVIATION 42.74 • n=7 Participants
|
182.7 lbs.
STANDARD_DEVIATION 45.46 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Ten investigational and 9 control subjects were evaluable for overall success while only 9 investigational and 8 control subjects completed the study at 12-month follow-up. Two subjects were classified as "failure" due to related serious adverse event or additional surgery before completion of the study.
Overall success is reported as participants who met all of the following criteria: 1. radiographic union success; 2. success in weight bearing ability; 3. improvement in pain at the delayed healing site; 4. no serious adverse event classified as "implant-associated" or "implant/surgical procedure-associated" (device-related); 5.no additional surgical procedures classified as a failure.
Outcome measures
| Measure |
INFUSE/MASTERGRAFT
n=10 Participants
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=9 Participants
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Overall Success
|
7 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 monthsRadiographic union success (a component of overall success) was defined as complete disappearance of fracture lines or the presence of bridging bone across the delayed healing site as observed on at least three of the four cortices (anterior, posterior, medial, and lateral), using plain films. If there was more than one delayed healing fracture line, all fracture lines must have been united in order to be considered a successful fracture union.
Outcome measures
| Measure |
INFUSE/MASTERGRAFT
n=9 Participants
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=8 Participants
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Radiographic Union Success
|
9 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 monthsSuccess in weight bearing ability (a component of overall success) was defined that subject was able to bear weight without severe pain on the affected limb. The subject was asked to stand, bearing full weight on the affected limb in a single-leg stance without ambulatory assistance for 10 seconds. If the subject was able to do so without severe pain, a positive (success) response was recorded. If the subject was either unable to stand on the affected limb in a single-leg stance or declined to do so because of limb weakness, poor balance, or severe leg pain, a negative (failure) response was documented.
Outcome measures
| Measure |
INFUSE/MASTERGRAFT
n=9 Participants
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=8 Participants
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Success in Weight Bearing Ability
|
9 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 12 monthsAfter walking five or six steps, subjects rated their intensity of pain/discomfort at the delayed healing site using a numerical rating scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be". Subjects who were unable or declined to walk because of severe leg pain were considered to have a score of 10. Success for pain at the delayed healing site was defined as at least a 2-point improvement in pain from the pre-operative score. Success of pain status at the delayed healing site was a component of overall success.
Outcome measures
| Measure |
INFUSE/MASTERGRAFT
n=9 Participants
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=8 Participants
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Success of Pain Status at the Delayed Healing Site
|
7 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 12 monthsThe SMFA is an assessment tool that measures a subject's overall function for a broad range of musculoskeletal injuries and disorders. The SMFA results were summarized into two components, the dysfunctional index and the bother index. Success for the SMFA assessment was defined as any improvement post-operatively as compared to the pre-operative condition.
Outcome measures
| Measure |
INFUSE/MASTERGRAFT
n=9 Participants
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=8 Participants
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Success in Short Musculoskeletal Functional Assessment (SMFA)
SMFA Dysfunctional Index Success
|
7 participants
|
8 participants
|
|
Success in Short Musculoskeletal Functional Assessment (SMFA)
SMFA Bother Index Success
|
6 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 monthsSF-36 was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). Success was defined as any improvement in a subject's SF-36 PCS post-operatively as compared to the pre-operative condition.
Outcome measures
| Measure |
INFUSE/MASTERGRAFT
n=9 Participants
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=8 Participants
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Success in Short Form 36-Item (SF-36) Health Survey
|
8 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 12 monthsSubject who had a surgery after the original study treatment was classified as a treatment "failure" if the additional surgery or treatment occurred in the involved limb and affected the study treatment and/or its mechanism of action in relation to the diagnosis or condition of the subject that was the cause for having the original study treatment.
Outcome measures
| Measure |
INFUSE/MASTERGRAFT
n=11 Participants
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=12 Participants
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Number of Subjects Having Additional Surgical Procedure Classified as a Treatment "Failure"
|
1 participants
|
1 participants
|
Adverse Events
INFUSE/MASTERGRAFT
Autograft Bone
Serious adverse events
| Measure |
INFUSE/MASTERGRAFT
n=11 participants at risk
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=12 participants at risk
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Cardiac disorders
Pericardial effusion
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Infections and infestations
Cellulitis
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Infections and infestations
Postoperative wound infection
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Injury, poisoning and procedural complications
Incision site pain
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
9.1%
1/11 • Number of events 1 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
Other adverse events
| Measure |
INFUSE/MASTERGRAFT
n=11 participants at risk
Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
|
Autograft Bone
n=12 participants at risk
Patients received autograft bone with rigid internal fixation.
|
|---|---|---|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Nervous system disorders
Neuropathy peripheral
|
9.1%
1/11 • Number of events 1 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • All study periods
|
16.7%
2/12 • Number of events 2 • All study periods
|
|
General disorders
Device component issue
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
General disorders
Medical device complication
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
General disorders
Medical device discomfort
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
General disorders
Medical device pain
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
General disorders
Oedema
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
General disorders
Oedema peripheral
|
27.3%
3/11 • Number of events 3 • All study periods
|
25.0%
3/12 • Number of events 3 • All study periods
|
|
General disorders
Pain
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
General disorders
Pyrexia
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Infections and infestations
Cellulitis
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Injury, poisoning and procedural complications
Incision site pain
|
9.1%
1/11 • Number of events 1 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Injury, poisoning and procedural complications
Nerve injury
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.1%
1/11 • Number of events 2 • All study periods
|
0.00%
0/12 • All study periods
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Investigations
Haemoglobin decresed
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • All study periods
|
16.7%
2/12 • Number of events 2 • All study periods
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1 • All study periods
|
16.7%
2/12 • Number of events 2 • All study periods
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Number of events 1 • All study periods
|
0.00%
0/12 • All study periods
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
|
Vascular disorders
Haematoma
|
0.00%
0/11 • All study periods
|
8.3%
1/12 • Number of events 1 • All study periods
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60