Trial Outcomes & Findings for Outcomes in Rotator Cuff Repair Using Graft Reinforcement (NCT NCT01025037)

NCT ID: NCT01025037

Last Updated: 2015-01-26

Results Overview

The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, \& Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: baseline, post-op months 3, 6, 12, and 24
• Results posted on: 2015-01-26

Participant Flow

Participant milestones

Measure	Conexa Rotator cuff repair using Conexa
Overall Study STARTED	61
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Conexa Rotator cuff repair using Conexa
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Outcomes in Rotator Cuff Repair Using Graft Reinforcement

Baseline characteristics by cohort

Measure	Conexa n=61 Participants Rotator cuff repair using Conexa
Age, Continuous	56.4 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 participants n=5 Participants
Race/Ethnicity, Customized White	56 participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants
Height	171.5 cm STANDARD_DEVIATION 11.3 • n=5 Participants
Weight	94.9 kg STANDARD_DEVIATION 24.9 • n=5 Participants
BMI	32 kg/m^2 STANDARD_DEVIATION 6.8 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, post-op months 3, 6, 12, and 24

The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, & Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.

Outcome measures

Measure	Conexa n=61 Participants Rotator cuff repair using Conexa
American Shoulder and Elbow Score (ASES) Baseline Measurement	48.7 units on a scale Standard Deviation 20.2
American Shoulder and Elbow Score (ASES) 3 Month Measurement	69.4 units on a scale Standard Deviation 16.2
American Shoulder and Elbow Score (ASES) 6 Month Measurement	79.9 units on a scale Standard Deviation 17.7
American Shoulder and Elbow Score (ASES) 12 Month Measurement	85.4 units on a scale Standard Deviation 18.4
American Shoulder and Elbow Score (ASES) 24 Month Measurement	90.4 units on a scale Standard Deviation 15.3

PRIMARY outcome

Timeframe: baseline, post-op months 6, 12, and 24

The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living - sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller & Uhl, 2005).

Outcome measures

Measure	Conexa n=61 Participants Rotator cuff repair using Conexa
Adjusted Constant-Murley Score Baseline Measurement	45.4 units on a scale Standard Deviation 15.2
Adjusted Constant-Murley Score 6 Month Measurement	62.9 units on a scale Standard Deviation 11.6
Adjusted Constant-Murley Score 12 Month Measurement	68.7 units on a scale Standard Deviation 11.3
Adjusted Constant-Murley Score 24 Month Measurement	71.7 units on a scale Standard Deviation 9.6

PRIMARY outcome

Timeframe: baseline, post-op months 3, 6, 12, and 24

The Simple Shoulder Test (SST): a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure & Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome.

Outcome measures

Measure	Conexa n=61 Participants Rotator cuff repair using Conexa
Simple Shoulder Test (SST) Baseline Measurement	5.0 units on a scale Standard Deviation 2.6
Simple Shoulder Test (SST) 3 Month Measurement	6.4 units on a scale Standard Deviation 3.0
Simple Shoulder Test (SST) 6 Month Measurement	8.7 units on a scale Standard Deviation 2.7
Simple Shoulder Test (SST) 12 Month Measurement	9.9 units on a scale Standard Deviation 2.5
Simple Shoulder Test (SST) 24 Month Measurement	10.6 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Post-op months 6 and 12

Population: Participants were analyzed at 6 and 12 months post-op. 2 participants not analyzed due to exclusion prior to 6 month post op visit.

Subjects will have MRI to assess healing of the repaired tendon at 6 and 12 months post-op. The rate of re-tear will be reported.

Two different definitions of a re-tear were used for the analysis.

1. Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size.

2. Sub-analysis: Full thickness tear one centimeter or greater in length.

Outcome measures

Measure	Conexa n=59 Participants Rotator cuff repair using Conexa
Rotator Cuff Re-tear Evaluation 80% re-tear Definition, 6 months	18.5 percentage of participants
Rotator Cuff Re-tear Evaluation 80% re-tear definition, 12 months	16.9 percentage of participants
Rotator Cuff Re-tear Evaluation 1 cm re-tear definition, 6 months	32.2 percentage of participants
Rotator Cuff Re-tear Evaluation 1 cm re-tear definition, 12 months	33.9 percentage of participants

SECONDARY outcome

Timeframe: baseline, post-op months 6, 12, and 24

Outcome measures

Measure	Conexa n=61 Participants Rotator cuff repair using Conexa
Isometric Strength Baseline Measurement	34.4 newtons (N) Standard Deviation 26.8
Isometric Strength 6 Month Measurement	61.9 newtons (N) Standard Deviation 52.8
Isometric Strength 12 Month Measurement	83.0 newtons (N) Standard Deviation 71.7
Isometric Strength 24 Month Measurement	78.6 newtons (N) Standard Deviation 63.2

OTHER_PRE_SPECIFIED outcome

Timeframe: All time points

Complications were summarized by reporting adverse events of special interest. AEs of special interest were defined as any reported infection (incision, wound, surgical site), seroma, hematoma, inflammation (surgical site, wound), and re-tear. The re-tear rate reported in this section is the number reported via AE or surgical intervention (not the MRI results). The AEs of special interest were chosen because they are in alignment with the potential complications listed on the product insert.

Outcome measures

Measure	Conexa n=61 Participants Rotator cuff repair using Conexa
Incidence of Complications, Including Infection Inflammation (surgical site, wound);Severity: Mild	9.8 percentage of participants
Incidence of Complications, Including Infection Re-tear;Severity: Mild	9.8 percentage of participants

Adverse Events

Conexa

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Conexa n=61 participants at risk Rotator cuff repair using Conexa
Infections and infestations Wound Infection	1.6% 1/61

Other adverse events

Measure	Conexa n=61 participants at risk Rotator cuff repair using Conexa
Injury, poisoning and procedural complications Mild Rotator Cuff Syndrome	13.1% 8/61
Injury, poisoning and procedural complications Moderate Rotator Cuff Syndrome	8.2% 5/61
Musculoskeletal and connective tissue disorders Mild Musculoskeletal Pain	16.4% 10/61
Musculoskeletal and connective tissue disorders Mild Inflammation (surgical site, wound)	9.8% 6/61
Musculoskeletal and connective tissue disorders Re-Tear	9.8% 6/61

Additional Information

Manager of Clinical Operations

Tornier, Inc.

Phone: 952-426-7674

Email: serickson@tornier.com

Results disclosure agreements

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

Restriction type: LTE60