NCT06605560

Brief Summary

Enlargement of any bursa in or around the popliteal fossa (most commonly the gastrocnemio-semimembranosus (GS) bursa) is called a Baker cyst (BC). Common clinical manifestations of BCs are swelling, mass, pain or stiffness, usually worsening with activity. There may be swelling and tightness or pain behind the knee when walking. However, the majority of these cysts are asymptomatic. They can be detected incidentally in the general population but are more commonly found in patients with osteoarthritis of the knee. In previous studies, aspiration or corticosteroid treatment was frequently used to treat baker's cysts in patients with osteoarthritis and meniscal or ligamentous injuries. However, there is no previous study in the literature showing the efficacy of PRP injection in baker's cyst. In our study, we aimed to compare the efficacy of cyst aspiration and PRP injection into the cyst on pain, function and cyst size compared to cyst aspiration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

September 18, 2024

Last Update Submit

August 19, 2025

Conditions

Keywords

Knee OsteoarthritisBaker CystPlatelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

  • Change from enrollment in the numeric rating scale for pain

    The numeric rating scale for pain that is a unidimensional measure of pain intensity in adults, including those with chronic pain.The common format is a horizontal bar or line. Similar to the visual analog scale, the numeric rating scale for pain is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from 0 representing one pain extreme (e.g. "no pain") to 11 representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    (1) From enrollment to the end of treatment at 6 weeks, (2) From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

  • Change from enrollment in the Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    (1) From enrollment to the end of treatment at 6 weeks, (2) From enrollment to the end of treatment at 12 weeks

  • Change in cyst dimensions (width x length)

    (1) From enrollment to the end of treatment at 6 weeks, (2) From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Aspiration group

NO INTERVENTION

The existing Baker's cyst of patients in this group will be aspirated under ultrasonographic guidance.

PRP+Aspiration group

EXPERIMENTAL

The existing Baker's cyst of patients in this group will be aspirated under ultrasonography guidance and PRP injection will be administered into the cyst.

Other: Platelet Rich Plasma

Interventions

PRP contains a high concentration of platelets obtained by centrifugation of autologous blood. After degranulation of platelets, various growth factors and cytokines are released and accelerate cartilage matrix synthesis, restrain synovial membrane inflammation and promote cartilage healing.

PRP+Aspiration group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of grade 1-2-3 knee osteoarthritis according to Kellgren Lawrence classification
  • Presence of a baker cyst (popliteal cyst) with at least one of the width or length measurements \>1 cm (proven by magnetic resonans imaging or muskuloskeletal ultrasound examination)

You may not qualify if:

  • Patients with grade 4 knee osteoarthritis according to the Kellgren Lawrence classification
  • Presence of secondary causes other than gonarthrosis which may lead to the development of a Baker cyst, such as meniscopathy, rheumatic diseases or anterior cruciate ligament damage, etc.
  • Long-term use (more than 3 months) of corticosteroid-containing medication
  • History of hyaluronic acid injection into the knee within the last 6 months or corticosteroid injection within the last 3 months
  • Skin lesions in and around the knee area in the last 7 days
  • Current Hb value \<12 or platelet value \<150,000
  • Immunologic or connective tissue disease
  • Patients with lateral knee joint space narrowing more than medial
  • History of previous knee surgery
  • History of pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Çelebi University

Izmir, Turkey (Türkiye)

Location

Related Publications (9)

  • Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015.

    PMID: 25624776BACKGROUND
  • Deasy BM, Feduska JM, Payne TR, Li Y, Ambrosio F, Huard J. Effect of VEGF on the regenerative capacity of muscle stem cells in dystrophic skeletal muscle. Mol Ther. 2009 Oct;17(10):1788-98. doi: 10.1038/mt.2009.136. Epub 2009 Jul 14.

    PMID: 19603004BACKGROUND
  • Braun HJ, Wasterlain AS, Dragoo JL. The use of PRP in ligament and meniscal healing. Sports Med Arthrosc Rev. 2013 Dec;21(4):206-12. doi: 10.1097/JSA.0000000000000005.

    PMID: 24212368BACKGROUND
  • Zhao L, Kaye AD, Abd-Elsayed A. Stem Cells for the Treatment of Knee Osteoarthritis: A Comprehensive Review. Pain Physician. 2018 May;21(3):229-242.

    PMID: 29871367BACKGROUND
  • Xie X, Zhang C, Tuan RS. Biology of platelet-rich plasma and its clinical application in cartilage repair. Arthritis Res Ther. 2014 Feb 25;16(1):204. doi: 10.1186/ar4493.

    PMID: 25164150BACKGROUND
  • Rauschning W. Popliteal cysts (Baker's cysts) in adults. II. Capsuloplasty with and without a pedicle graft. Acta Orthop Scand. 1980 Jun;51(3):547-55. doi: 10.3109/17453678008990839.

    PMID: 7004054BACKGROUND
  • Johnson LL, van Dyk GE, Johnson CA, Bays BM, Gully SM. The popliteal bursa (Baker's cyst): an arthroscopic perspective and the epidemiology. Arthroscopy. 1997 Feb;13(1):66-72. doi: 10.1016/s0749-8063(97)90211-5.

    PMID: 9043606BACKGROUND
  • Sansone V, De Ponti A. Arthroscopic treatment of popliteal cyst and associated intra-articular knee disorders in adults. Arthroscopy. 1999 May;15(4):368-72. doi: 10.1016/s0749-8063(99)70053-8.

    PMID: 10355711BACKGROUND
  • Handy JR. Popliteal cysts in adults: a review. Semin Arthritis Rheum. 2001 Oct;31(2):108-18. doi: 10.1053/sarh.2001.27659.

    PMID: 11590580BACKGROUND

MeSH Terms

Conditions

PainPopliteal CystOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSynovial CystCystsNeoplasmsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ayhan Aşkın, Professor

    Izmir Katip Çelebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 20, 2024

Study Start

September 15, 2024

Primary Completion

August 12, 2025

Study Completion

August 19, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations