Clinical trial NCT06136286: ORIF Distal Radius Blood Flow Restriction Therapy
Official title: Effects of Blood Flow Restriction Rehabilitation After ORIF of Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a prospective randomized control trial consisting of subjects requiring ORIF of the distal radius. Subjects will be divided into two groups based on age, then subsequently be randomly divided into two groups following their inclusion in the study. Group 1) Control group in which subjects receive standard of care rehab. Group 2) BFR group in which BFR is incorporated into the patients' rehab.

Groups will be normalized based on gender. One group will undergo the normal rehabilitation protocol for the hand and wrist as determined by Dr. Liberman. The study group will undergo rehabilitation protocol for distal radius fractures modified by use of a tourniquet for blood flow restriction during selected exercises.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients commonly experience a significant amount of muscular atrophy following open reduction internal fixation (ORIF) surgery of distal radius fractures, associated with an increased risk of re-injury, and an increase in time of recovery. A combination of low intensity resistance exercise and blood flow restriction (BFR) therapy has been shown to elicit responses similar to high intensity resistance exercise with reduced risk. We hypothesize that chronic low intensity resistance exercise combined with BFR will improve muscular strength, reduce skeletal muscle atrophy, and will enhance recovery.

Therefore, the specific aims of this study are as follows:

1. Determine if BFR added to standard post-operative rehab will prevent skeletal muscle atrophy and promote skeletal muscle growth during 12-weeks of rehab training compared to traditional rehab alone. The working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle growth and prevent atrophy to a greater extent than rehab alone.
2. Determine if BFR added to standard post-operative rehab will improve muscular strength following surgery compared to traditional rehab alone. Because strength can be attributed to skeletal muscle mass, the working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle strength and fatigue resistance to a greater extent than rehab alone.
3. Determine if BFR added to standard post-operative rehab will improve functional outcomes following surgery compared to traditional rehab alone. The working hypothesis, founded on previous literature is that BFR will improve functional outcomes over rehab alone.

Detailed description: he study will be a prospective randomized control trial consisting of subjects requiring ORIF of the distal radius. Subjects will be divided into two groups based on age, then subsequently be randomly divided into two groups following their inclusion in the study.

Groups will be normalized based on gender. One group will undergo the normal rehabilitation protocol for the hand and wrist as determined by Dr. Liberman. The study group will undergo rehabilitation protocol for distal radius fractures modified by use of a tourniquet for blood flow restriction during selected exercises. On the day of the procedure, the surgeon will measure the subject's forearm girth, the location of the largest circumference. The subject will then undergo the normal operative fixation of the distal radius fracture. A subject will be excluded from the study if they have had any prior surgeries on their affected wrist. At the subject's two week postoperative clinic visit, the physician will measure forearm girth. Study group subjects will begin physical therapy instructed BFR exercises at two weeks post operatively. Study group subjects will be taken through normal hand and wrist rehab protocol as well as BFR exercises. Control group subjects will do the same exercises and formal physical therapy rehab protocol as the study group without BFR.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18+
* With acute fracture of distal radius requiring ORIF surgery

Exclusion Criteria:

* Exorbitant pain (VAS \>8/10) related or unrelated to exercise
* Prior trauma or surgery to the observed limb
* Level 2 Obesity (BMI\>35)
* Diabetes - Type II
* Cardiovascular, renal, liver or pulmonary disease
* Active infections
* Cancer (current or treated within the past 2 years)
* Bleeding or coagulation disorder
* Rapid weight change within the past year
* Physically unable to participate in the intervention
* Currently taking, or recently (w/in 1month of participation) taken prescribed or over the counter ergogenic aids or compounds known to be banned by the NCAA
* Unable to complete a minimum of 85% of the assigned rehabilitation sessions

Primary outcomes:
measure: Body composition / bone density
timeFrame: DEXA scans will be recorded at the first rehabilitation visit (one week post-op), and then at two weeks, six weeks and 12 weeks following the initiation of rehabilitation.
measure: Forearm girth
timeFrame: Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.
measure: Grip strength
timeFrame: Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.
measure: Pinch grip strength
timeFrame: Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.
Secondary outcomes:
measure: DASH survey
timeFrame: This survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.
measure: Michigan Hand Outcomes survey
timeFrame: This survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.
measure: Patient Rated Wrist Evaluation
timeFrame: This survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Shari Liberman, MD
role: PRINCIPAL_INVESTIGATOR
References: