NCT07307118

Brief Summary

This single-group longitudinal study evaluated changes in hip stability isometric strength, knee muscle strength, and activity-related pain in women with knee osteoarthritis following a single-dose intra-articular platelet-rich plasma (PRP) injection and a 6-week home exercise program. Outcomes were assessed at baseline (5 days post-injection), week 6, and week 12. The intervention included strengthening exercises for knee and hip muscle groups performed three times per week and regular walking encouragement with weekly phone follow-up for adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 13, 2025

Last Update Submit

December 13, 2025

Conditions

Keywords

Knee osteoarthritisexercise therapyhip muscle strengthplatelet-rich plasmaHand-held dynamometerPain

Outcome Measures

Primary Outcomes (1)

  • Hip Stability Isometric Test (HipSIT) strength (N/kg), affected side

    Hip stability isometric strength (combined hip extensor, abductor and external rotator maximum isometric strength) assessed using a hand-held dynamometer during the Hip Stability Isometric Test (HipSIT). The test is performed in side-lying "clam" position (hip 45° flexion, knee 90° flexion). Three maximal trials (5 seconds each) are performed and the maximum force output (N) is normalized to body mass (N/kg).

    Baseline (5 days post PRP injection), Week 6, Week 12

Secondary Outcomes (3)

  • Quadriceps femoris isometric strength (N/kg), affected side

    Baseline (5 days post PRP injection), Week 6, Week 12

  • Hamstring isometric strength (N/kg), affected side

    Baseline (5 days post PRP injection), Week 6, Week 12

  • Knee pain during activity (Visual Analog Scale, 0-10)

    Baseline (5 days post PRP injection), Week 6, Week 12

Other Outcomes (1)

  • Strength symmetry indices (QI, HI, HipI), %

    Baseline (5 days post PRP injection), Week 6, Week 12

Study Arms (1)

Single Group: PRP Injection + Home Exercise Program

EXPERIMENTAL

All participants received a unilateral single-dose intra-articular platelet-rich plasma (PRP) injection for symptomatic knee osteoarthritis, followed by a 6-week home-based strengthening and functional exercise program performed 3 times per week. The exercise program targeted knee extensors/flexors and hip extensors/abductors/external rotators. Participants were encouraged to walk at least 30 minutes on at least 5 days per week and were contacted weekly by phone to support adherence.

Biological: Platelet-Rich Plasma (PRP) InjectionBehavioral: Home Exercise Program

Interventions

A single unilateral intra-articular autologous platelet-rich plasma (PRP) injection was administered to the affected knee. Baseline assessments were conducted 5 days following the injection.

Also known as: PRP
Single Group: PRP Injection + Home Exercise Program

Home-based exercise program performed 3 times per week for 6 weeks, designed to strengthen knee extensors/flexors and hip extensors/abductors/external rotators. Exercises included: quadriceps strengthening (supine isometric contractions with 5-second hold; seated knee extension with 5-second hold; straight leg raise with 5-second hold), hamstring strengthening (supine isometric contractions with 5-second hold; prone active knee flexion with 5-second hold), hip stabilizer strengthening (clamshells and side-lying hip abduction with 5-second hold), and functional exercises (step-ups, forward touchdowns from a step, side stepping, sit-to-stand from a chair without using arms, and partial wall squats), typically 10-15 repetitions. Participants were also encouraged to walk at least 30 minutes on at least 5 days per week, and adherence was supported via weekly telephone contact.

Single Group: PRP Injection + Home Exercise Program

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged 45-70 years.
  • Radiographic knee osteoarthritis: Kellgren-Lawrence grade II-III in the affected knee and grade II or less in the unaffected knee.
  • Unilateral knee pain during activity with VAS score ≥5 (for at least the past 3 months).
  • Referred to physiotherapy following a unilateral single-dose PRP injection.

You may not qualify if:

  • Any intra-articular knee injection within the past 6 months.
  • Regular lower-extremity strengthening exercise or non-pharmacological treatment for knee OA within the past 6 weeks.
  • History of lower-extremity surgery.
  • History of neurological, rheumatological and/or cognitive diseases.
  • Unable to use a telephone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat Üniversitesi

Elâzığ, MErkez, 23200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Injections

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 13, 2025

First Posted

December 29, 2025

Study Start

July 8, 2025

Primary Completion

December 12, 2025

Study Completion

December 13, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations