Trial Outcomes & Findings for Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures (NCT NCT00556543)

NCT ID: NCT00556543

Last Updated: 2011-07-01

Results Overview

The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days
• Results posted on: 2011-07-01

Participant Flow

10 Study subjects were enrolled to the study over a 10 month period in 2007 (February to November and underwent surgical repair of their rib fracture injury. All subjects were recruited from the OHSU Hospital and Outpatient Clinic.Study approval was granted on 11/18/2006 by the OHSU Research Integrity Office.

6 of the consented study participants had acute rib fractures, 4 had chronic rib fracture non-unions.

Participant milestones

Measure	All Study Subjects
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures

Baseline characteristics by cohort

Measure	All Study Subjects n=10 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	46.5 years STANDARD_DEVIATION 22.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Rib Fracture Rib Fracture, Acute	6 Participants n=5 Participants
Rib Fracture Rib Fracture, Chronic Non-Union	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Population: Per Protocol

Clinical evaluations or chest radiographs at a minimum of 1 and 6 months

Outcome measures

Measure	Acute Rib Fracture Repair n=6 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union n=4 Participants Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
Adverse Post-op Events Related to the Repair and Plating System	1 Participants	3 Participants

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The Rand 36-Item Health Survey Results - Physical Functioning Scale	65.6 RAND-36 scale units Standard Deviation 22.8	—

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale	33.3 RAND-36 scale units Standard Deviation 35.4	—

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale	81.4 RAND-36 scale units Standard Deviation 37.7	—

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The Rand 36-Item Health Survey Results - Vitality Scale	57.2 RAND-36 scale units Standard Deviation 18.9	—

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The Rand 36-Item Health Survey Results - Emotional Well-being Scale	73.3 RAND-36 scale units Standard Deviation 13.1	—

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The Rand 36-Item Health Survey Results - Social Functioning Scale	76.4 RAND-36 scale units Standard Deviation 25.3	—

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The Rand 36-Item Health Survey Results - Bodily Pain Scale	66.0 RAND-36 scale units Standard Deviation 24.4	—

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The Rand 36-Item Health Survey Results - General Health Scale	62.2 RAND-36 scale units Standard Deviation 20.8	—

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)	1.22 PPI Standard Deviation 0.97	—

PRIMARY outcome

Timeframe: results at 60, 120, and 180 days post-repair with results posted for 180 days

Population: Per Protocol

The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.

Outcome measures

Measure	Acute Rib Fracture Repair n=10 Participants These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Rib Fracture Repair for Persistent Rib Fracture Non-Union Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)	17.78 PRI Standard Deviation 15.58	—

Adverse Events

Acute Rib Fracture Repair

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Chronic Rib Fracture Non-union Repair

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acute Rib Fracture Repair n=6 participants at risk	Chronic Rib Fracture Non-union Repair n=4 participants at risk
Infections and infestations Acute repair adverse event	16.7% 1/6 • Number of events 1 • Enrolled subjects were followed for 6 months following surgical repair of their rib fracture. Subjects were evaluated with radiographic evaluations (chest x-rays) at a minimum of 1 and 6 months. Subjects completed the McGill Pain Questionnaire and the Rand 36 Health Survey at serial intervals during the 6 months of study participation.	— 0/0 • Enrolled subjects were followed for 6 months following surgical repair of their rib fracture. Subjects were evaluated with radiographic evaluations (chest x-rays) at a minimum of 1 and 6 months. Subjects completed the McGill Pain Questionnaire and the Rand 36 Health Survey at serial intervals during the 6 months of study participation.
Surgical and medical procedures Chronic non-union repair	— 0/0 • Enrolled subjects were followed for 6 months following surgical repair of their rib fracture. Subjects were evaluated with radiographic evaluations (chest x-rays) at a minimum of 1 and 6 months. Subjects completed the McGill Pain Questionnaire and the Rand 36 Health Survey at serial intervals during the 6 months of study participation.	25.0% 1/4 • Number of events 1 • Enrolled subjects were followed for 6 months following surgical repair of their rib fracture. Subjects were evaluated with radiographic evaluations (chest x-rays) at a minimum of 1 and 6 months. Subjects completed the McGill Pain Questionnaire and the Rand 36 Health Survey at serial intervals during the 6 months of study participation.

Additional Information

John Mayberry, MD

Oregon Health & Science University

Phone: 503-494-5300

Email: mayberrj@ohsu.edu

Results disclosure agreements

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