Post Operative Pain
Conditions
Keywords
PRP, BPTB, VAS, Anterior Knee Pain
Brief summary
The purpose of this research study is to investigate whether or not platelet rich plasma (PRP) may help to improve tendon healing and decrease post operative pain in patients undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar tendons as autografts.
Detailed description
There is currently a paucity of well-designed, prospective, randomized, blinded (Level 1) clinical studies that carefully and comprehensively investigate the role of PRP in ACL surgery. Specifically, ACL reconstruction using Bone Patellar Tendon Bone (BPTB) harvest and the role of PRP in decreasing postoperative pain at the donor site. Given the need for a highly powered study to demonstrate the clinical efficacy of PRP in ACL reconstruction, the investigators have designed a prospective, randomized, level 1, double-blinded study to evaluate the effects of PRP on the specific outcomes of donor site pain and radiographic measures of graft healing and incorporation. The aim of this study is to evaluate the efficacy of intra-operatively applied autologous PRP in reducing donor site morbidity and increasing radiographic healing in ACL reconstruction using autologous BPTB.
Interventions
PROCEDUREAnterior Cruciate ligament reconstruction bone patellar tendon bone autograft
BIOLOGICALPlatelet Rich Plasma
Sponsors
Brian Walters
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Primary ACL Reconstruction * Outerbridge \</= 2 * Minimum follow up of two years * No ligamentous secondary injury * Willingness to participate in study
Exclusion criteria
* Any previous knee injury * prior history of anterior knee pain * Outerbridge classification 3 or greater * Revision ACL * Diabetic or smoker * Workers compensation patient * pregnant or nursing women * Any patient with limited English Proficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Knee Pain | 2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported. | The primary outcome measured will be anterior knee pain. The investigators will do so by using Visual Analog Scales as an assessment tool. The visual analog scales will include pain with activities of daily living and pain with kneeling activities. Information regarding these pain scales will be collected at 14 days and 1,3,6,12,18 and 24 months. The Visual analog Scale is a score from 0-10 with 0=no pain and 10=excruciating pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Assessment of Tunnel Positioning | 3 months | A triple view radiographic series of the knee will be performed to assess the position of the tibial and femoral tunnels by one blinded senior radiologist. |
| Quantification of Healing at the Bony and Tendinous Harvest Sites | 6 months | Post-op MRI's will be obtained to quantify the amount of bony healing at the donor site and revascularization of native patellar tendon at the harvest site. These images will be interpreted by one blinded senior musculoskeletal radiologist. |
| Post Operative Strength | 3,6,12,18,24months | The objective clinical assessment of strength in the operative extremity will measured as quadriceps strength in a single leg hop test. This data will be collected by an independent researcher also blinded to treatment. |
| Post Operative Range of Motion | 2 weeks, 1,3,6,12,18,24months | The patients range of motion will be assessed on both the operative and non-operative knee. This information will be assessed using a goniometer and will be collected by a blinded clinician. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRP Treatment 27 patients received the PRP treatment | 27 |
| Sham Treatment 23 patients received the sham treatment | 23 |
| Total | 50 |
Baseline characteristics
| Characteristic | Sham Treatment | Total | PRP Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 50 Participants | 27 Participants |
| Age, Continuous | 29 years STANDARD_DEVIATION 12 | 30 years STANDARD_DEVIATION 12 | 31 years STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 23 participants | 50 participants | 27 participants |
| Sex: Female, Male Female | 11 Participants | 28 Participants | 17 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 23 |
| other Total, other adverse events | 0 / 27 | 0 / 23 |
| serious Total, serious adverse events | 0 / 27 | 0 / 23 |
Outcome results
Primary
Anterior Knee Pain
The primary outcome measured will be anterior knee pain. The investigators will do so by using Visual Analog Scales as an assessment tool. The visual analog scales will include pain with activities of daily living and pain with kneeling activities. Information regarding these pain scales will be collected at 14 days and 1,3,6,12,18 and 24 months. The Visual analog Scale is a score from 0-10 with 0=no pain and 10=excruciating pain.
Time frame: 2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.
Population: Kneeling pain for treatment groups at 2 years post-op.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRP Treatment | Anterior Knee Pain | 2.4 units on a scale | Standard Deviation 2.7 |
| Sham | Anterior Knee Pain | 1.9 units on a scale | Standard Deviation 1.6 |
p-value: 0.5595% CI: [-1.99, 1.03]t-test, 2 sided
Secondary
Post Operative Range of Motion
The patients range of motion will be assessed on both the operative and non-operative knee. This information will be assessed using a goniometer and will be collected by a blinded clinician.
Time frame: 2 weeks, 1,3,6,12,18,24months
Population: ROM was not measured
Secondary
Post Operative Strength
The objective clinical assessment of strength in the operative extremity will measured as quadriceps strength in a single leg hop test. This data will be collected by an independent researcher also blinded to treatment.
Time frame: 3,6,12,18,24months
Population: Strength was not assessed
Secondary
Quantification of Healing at the Bony and Tendinous Harvest Sites
Post-op MRI's will be obtained to quantify the amount of bony healing at the donor site and revascularization of native patellar tendon at the harvest site. These images will be interpreted by one blinded senior musculoskeletal radiologist.
Time frame: 6 months
Population: MRI indices of donor site healing - defect in millimeters (mm)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRP Treatment | Quantification of Healing at the Bony and Tendinous Harvest Sites | 11.6 mm | Standard Deviation 2.4 |
| Sham | Quantification of Healing at the Bony and Tendinous Harvest Sites | 12.0 mm | Standard Deviation 3.1 |
Secondary
Radiographic Assessment of Tunnel Positioning
A triple view radiographic series of the knee will be performed to assess the position of the tibial and femoral tunnels by one blinded senior radiologist.
Time frame: 3 months
Population: Was not measured