Platelet Rich Plasma vs Open Surgery in the Treatment of Tennis Elbow

NCT02755727 | Completed

• 1 other identifier: 1510155
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Lateral Epicondylar Tendinopathy is a debilitating condition that is associated with repetitive use of the forearm extensor muscles. Though often self-limiting in nature there are a proportion of patients who fail to respond to conservative treatments such as rest, activity modification, physiotherapy and the use of a brace. Though previously a common treatment modality steroid injections have been shown to be detrimental in the longer term. Present practice is to offer those patients who do not respond to conservative treatment surgical debridement. Though often effective this is an invasive procedure. Platelet rich plasma injections may offer a viable alternative in chronic cases however there is no systematic evidence of its efficacy. Methods 12 patients, diagnosed with chronic lateral epicondylar tendinopathy, will be randomly assigned to receive either open surgical debridement or platelet rich plasma injections. Following treatment, they will be followed up at intervals of 6 weeks and 3, 6 and 12 months. The outcome of each treatment will be assessed using validated outcome scoring measures specifically designed for upper limb pathology. The results of this pilot study will be used to construct a larger randomised control trial.

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (1)

• Change in Patient Rated Tennis Elbow Evaluation (PRTEE)

  patient compiled questionnaire based on specific elbow symptoms of Tennis Elbow

  To be completed pre-intervention and at 3 months post-intervention

Secondary Outcomes (4)

• Change in Visual Analogue Scale (VAS)

  To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention

• Change in Disabilities of the Arm, Shoulder and Hand (quickDASH)

  To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention

• Change in Oxford Elbow Score (OES)

  To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention

• Adverse events

  peri-procedural, 6 weeks, 3 months, 6 months and 12 months

Study Arms (2)

Platelet Rich Plasma injection

EXPERIMENTAL

In the outpatient setting a sample of venous whole blood will be taken from the patient (40mls), from the antecubital fossa using standard phlebotomy techniques. The Angel™ system will be in the available also in the outpatient clinic and will be used to separate the blood to yield a PRP sample (approximately 15 minutes preparation time). The PRP sample is then injected into the common extensor origin. 2 injections will be used per patient over 2 weeks.

Procedure: Platelet Rich Plasma Injection

Open Surgical Release

ACTIVE COMPARATOR

Standardised surgical technique based on the Nirschl technique will be used. The patient will then have a small scar centred over the lateral epicondyle and the plane opened between ECRL (Extensor Carpi Radialis Longus) and EDC (Extensor Digitorum Communis) to expose the damaged ECRB (Extensor Carpi Radialis Brevis) tendon. The amount of abnormal tendon will be documented and excised. EDC will also be inspected and any abnormal tissue documented then excised. The footprint of the excised ECRB +/- EDC is cleared of soft tissue and the bone scored with an osteotome to promote bleeding. The interval is closed with suture material and the skin wound closed.

Procedure: Open Surgical Release

Interventions

Platelet Rich Plasma Injection PROCEDURE

See Arms

Platelet Rich Plasma injection

Open Surgical Release PROCEDURE

See arms

Open Surgical Release

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient who:
• Has experienced more than 6 months of symptoms from tennis elbow (pain on the lateral elbow that radiates down the forearm, point tenderness over the origin of the extensor muscles or at its close proximity (within 2.5cm) and pain on resisted extension of the Wrist).
• Patients must also have failed conservative treatment (a course of physiotherapy and activity modification)
• Baseline elbow pain \>3/10 on VAS during resisted elbow extension.

You may not qualify if:

• Presence of a full tendon tear on pre-intervention ultrasound
• Unfit for surgical intervention
• Have undergone previous elbow surgery,
• Have previously undergone PRP injection therapy
• Systemic autoimmune rheumatological disease
• Receiving immunosuppressive treatments
• Received local steroid injection within 3 months of randomization
• Unable to comply with follow-up.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Royal Deveon and Exeter Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• C Gardener

  Research Development Directorate - Royal Devon and Exeter Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 29, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: September 29, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)