Trial Outcomes & Findings for The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction (NCT NCT01765712)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.

Results posted on

2021-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	PRP Treatment Patients treated with PRP	Sham Patients not receiving PRP
Overall Study STARTED	27	23
Overall Study COMPLETED	27	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRP Treatment n=27 Participants 27 patients received the PRP treatment	Sham Treatment n=23 Participants 23 patients received the sham treatment	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=27 Participants	0 Participants n=23 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=27 Participants	23 Participants n=23 Participants	50 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=27 Participants	0 Participants n=23 Participants	0 Participants n=50 Participants
Age, Continuous	31 years STANDARD_DEVIATION 12 • n=27 Participants	29 years STANDARD_DEVIATION 12 • n=23 Participants	30 years STANDARD_DEVIATION 12 • n=50 Participants
Sex: Female, Male Female	17 Participants n=27 Participants	11 Participants n=23 Participants	28 Participants n=50 Participants
Sex: Female, Male Male	10 Participants n=27 Participants	12 Participants n=23 Participants	22 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	27 participants n=27 Participants	23 participants n=23 Participants	50 participants n=50 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	PRP Treatment n=27 Participants Patients treated with PRP	Sham n=23 Participants Patients not receiving PRP
Anterior Knee Pain	2.4 units on a scale Standard Deviation 2.7	1.9 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 3 months

Population: Was not measured

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: MRI indices of donor site healing - defect in millimeters (mm)

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.

Outcome measures

Outcome measures
Measure	PRP Treatment n=27 Participants Patients treated with PRP	Sham n=23 Participants Patients not receiving PRP
Quantification of Healing at the Bony and Tendinous Harvest Sites	11.6 mm Standard Deviation 2.4	12.0 mm Standard Deviation 3.1

SECONDARY outcome

Timeframe: 3,6,12,18,24months

Population: Strength was not assessed

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks, 1,3,6,12,18,24months

Population: ROM was not measured

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.

Outcome measures

Outcome data not reported

Adverse Events

PRP Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Malachy McHugh Director of Research

Nicholas Institute of Sports Medicine and Athletic Trauma

Phone: 2124342714

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place